Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Yes
3) Blinding of outcome assessors: Yes‐all staff, other than anaesthetist
No‐anesthetist
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 100
Drop outs/Withdrawals: 1
Incl. Criteria: 1) Patients scheduled for complete colonoscopy 2) Age 17‐75 years 3) ASA class I‐III
Excl. Criteria: 1) Patients with pulmonary, neurological and metabolic diseases 2) History of allergic reaction to any of the study drugs 3) Chronic use of opioid analgesics 4) Pregnancy
Country: Turkey
Setting: Not stated
Age(median(range) )(yrs): Group A: 40 (17‐74) Group B: 48 (18‐75)
N (%) males: Group A: 28 (56) Group B: 26(53)
ASA score (I/II/III): Group A: 15/15/20 Group B: 17/12/20
Groups comparable at baseline: Yes (age, sex ratio, body weight, height, ASA score, baseline anxiety score)

Interventions

Group A (n=50): Propofol (Mean (SD) dose: 161.06 (52.2) mg) and Midazolam 2 mg (pre‐medication)
Group B (n=49): Remifentanil(Mean (SD) dose: 98.7 (45.05) micrograms) and Midazolam 2 mg (pre‐medication)
Mode of administration: Intial bolus, followed by continuous infusion and supplementary boluses
Administered by: Anesthesiologist
Goal level of sedation: Observer's Assessment of Alterness/Sedation scale score of 3
All received supplemental oxygen (3‐4 L/min) through face mask

Outcomes

Patients' level of sedation, pain, recovery time, discharge time, patient satisfaction, vital signs, gastroenterologist satisfaction

Notes

Definitions:
1) Recovery time: time to reach Aldrete score of nine or more in the recovery room. The paper also states that patients were admitted to recovery unit, after they achieved an Aldrete score of nine or more.
2) Discharge time: Stable vital signs, able to tolerate oral fluids, no nausea, vomiting or itching, and able to walk unaided
3) Sedation level: assessed on Observer's Assessment of Alertness/Sedation scale
4) Pain: evaluated during the procedure on a 11 point scale
5) Patient satisfaction: patients contacted via telephone the day after colonoscopy and asked about their satisfaction, which was assessed on a 4‐point scale

Methods

Randomized study

1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Not stated
3) Blinding of outcome assessors: Unclear/Not stated
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Unclear/Not stated

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 1,032
Drop outs/Withdrawals: Not stated
Incl. Criteria: Not stated
Excl. Criteria: Not stated
Country: Thailand
Setting: Not stated
Age(mean)(yrs): Not stated
(%) males: Not stated
ASA score :Not stated
Groups comparable at baseline: Not stated

Interventions

Group A (n=518): Propofol (mean total dose: 5.98 (2.67) mg/kg/hr) and Meperidine (mean total dose: 1.74 (1.05) mg/kg/hr)
Group B (n=514): Midazolam (mean total dose: 0.08 (0.05) mg/kg/hr) and Fentanyl (mean total dose: 0.003 (0.002) mg/kg/hr
There is mention of additional dosing with propofol in both groups‐‐which we ascribed as an error in the abstract
Mode of administration: Not stated
Administered by: Not stated
Goal level of sedation: Not stated
Supplemental oxygen: Not stated

Outcomes

Primary outcome: colonoscopy completion rate
Secondary outcomes: patient tolerance, discomfort during insertion, patient and endoscopist satisfaction, hemodynamic responses, as well as complications during and immediately after procedure

Notes

For the secondary outcomes, no scores or values are provided; only p values provided for some of the secondary outcomes. Hence results for the secondary outcomes from this study were not included in the meta‐analysis.

Methods

Multi center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: No
3) Blinding of outcome assessors: Unclear/Not stated
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: 82
Number of patients enrolled: 67
Drop outs/Withdrawals: 0
Incl. Criteria: Consecutive patients presenting for outpatient colonoscopy
Excl. Criteria: 1) Age less than 18 years 2) Patients with significant cardiorespiratory disease 3) previous colonic surgery 4) those judged unable to use PCS
Country: UK
Setting: Outpatient
Age(median(range))(yrs): Group A:49 (21‐84) Group B: 58 (23‐77)
N (%) males: Group A: 19 (56) Group B: 12 (36)
ASA score: Not stated
Groups comparable at baseline: Yes (age, body weight); more women in group B

Interventions

Group A (n=34): PCS Propofol (Median (range) dose: 5.5 (1.9‐12.8) mg/kg/hr) and Alfentanil (Median (range) dose: 13.8 (4.8‐32) micrograms/kg/hr)
Group B (n=33): Midazolam (Median (range) dose: 0.06 (0.03‐0.12) mg/kg) and Pethidine: single bolus dose of 50 mg
Mode of administration: Group A: PCS boluses Group B: single bolus of pethidine at beginning of procedure, followed by 2.5 mg of midazolam boluses at endoscopist's discretion
Administered by: Group A: PCS Group B: endoscopist; an anaesthetist present in observational capacity
Goal level of sedation: Group A (PCS): relieve patient discomfort Group B: Not stated
All received supplemental oxygen (2 L/min) through nasal cannula

Outcomes

Procedure time, patients' level of sedation, pain, complications, recovery time, discharge time, patient satisfaction, impact on normal activities

Notes

Definitions:
1) Patients' level of sedation, measured by a single nurse specialist during the procedure on a 5 point scale
2) Pain score: Patients' recollection, after recovery on a 4 point scale, measured by a single nurse specialist during the procedure. This outcome was dichomotomized for meta‐analysis as Moderate/Severe Pain vs. No/Mild Pain.
3) Recovery time: Removal of colonoscope to the patient's completion of a number connection test (NCT) to within 10% of their pre procedure time
4) Discharge time: When patient judged to be mobile with a steady gait
5) Complications: Determined by monitoring of blood pressure, heart rate and oxygen saturation
6) Patient Satisfaction: Patients completed a questionnaire concerning their satisfaction with the type of sedation received. No details or definitions provided

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: No
3) Blinding of outcome assessors: No
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 100
Drop outs/Withdrawals: 0
Incl. Criteria: Not stated
Excl. Criteria: Not stated
Country: France
Setting: Unclear/Not stated
Age(mean)(yrs): Group A: 54 Group B: 53.5
N (%) males: Group A: 23 (46) Group B: 27(54)
ASA score: Not stated
Groups comparable at baseline: Yes (age, gender, body weight)

Interventions

All patients were premedicated with 800mg of Cimetidine prior to the procedures
Group A (n=50): Propofol; Dose: Age < 65 yrs‐‐Induction: 1.5mg/kg Maintenance : 6 mg/kg/hr; Age >65 yrs‐‐Induction: 1.25 mg/kg Maintenance : 5 mg/kg/hr
Group B (n=50): Midazolam; Dose: Age < 65 yrs‐‐Induction: 0.15 mg/kg Maintenance: 0; Age > 65 yrs‐‐Induction: 0.1 mg/kg Maintenance: 0
Alfentanil ; Dose: Age < 65 yrs‐‐Induction: 0.01 mg/kg Maintenance: 0.06 mg/kg/hr; Dose: Age > 65 yrs‐‐Induction: 0.008 mg/kg Maintenance: 0.05 mg/kg/hr
Mode of administration: Both groups‐bolus induction, followed by maintenance infusion
Administered by: Anesthesiologist
Goal level of sedation: Not stated
All received supplemental oxygen (50%) through face mask

Outcomes

Recovery at different time points, after end of sedation
Vital signs at different time points
Apnea during induction

Notes

French language article
High induction dose
Definitions:
1) Recovery at different time points, after end of sedation judged by ability to complete Newman's 38 points connection test
2) Level of sedation judged subjectively by anaesthesiologists on a 5 point scale. No measures of significance or variation given‐‐hence not used in analysis
3) Apnea not defined, but numbers during induction given‐‐‐only outcome used in meta‐analysis

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Not stated
3) Blinding of outcome assessors: Not stated
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Unclear/Not stated

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 66
Drop outs/Withdrawals: 0
Incl. Criteria: Not stated
Excl. Criteria: Not stated
Country: Switzerland
Setting: Not stated
Age(mean)(yrs): Group A: 61 Group B: 62
(%) males: Group A: 50 Group B: 52
ASA score >II: Group A: 34% Group B: 25%
Groups comparable at baseline: Yes (age, gender, ASA score)

Interventions

Group A (n=33): Propofol (Mean (SD) dose: 117 (65) mg)
Group B (n=33): Midazolam (Mean(SD) dose: 5 (1.6) mg)
All patients also received alfentanil
Mode of administration: Not stated
Administered by: nurse, supervised by endoscopist
Goal level of sedation: "clinical need"
All received supplemental oxygen (4 L/min) through nasal cannula

Outcomes

Drops in oxygen saturation, increase in transcutaneous PCO2, patient satisfaction, endoscopist satisfaction

Notes

No major adverse events occurred during sedation.
Definitions:
1) Patient and endoscopist satisfaction were evaluated on a 10 cm VAS
2) Oxygen desaturations less than 90% reported

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear
2) Blinding of patients: Not stated
3) Blinding of outcome assessors: Not stated
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Unclear

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 83
Drop outs/Withdrawals: 0
Incl. Criteria: Not stated
Excl. Criteria: Not stated
Country: Switzerland
Setting: Unclear
Age: Not stated
N (%) males: Not stated
ASA score: Not stated
Groups comparable at baseline: Not stated

Interventions

Group A (n=41): Propofol (dose: not stated)
Group B (n=42): Midazolam (dose: not stated)
All patients also received 4 micrograms/ Kg Alfentanil
Mode of administration: Not stated
Administered by: Not stated
Goal level of sedation: Not stated
All received supplemental oxygen (3 L/min)

Outcomes

Hypoventilation as measured by changes in the transcutaneous carbon dioxide tension; hypoxemia (SpO2<85%); apnea

Notes

Definitions
1. Hypoxia: SpO2<85%

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Not stated
3) Blinding of outcome assessors: Unclear/Not stated
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Unclear/Not stated

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 7,286
Drop outs/Withdrawals: Unclear/Not stated
Incl. Criteria: Consecutive diagnostic colonoscopies performed during a 3 year period
Excl. Criteria: Therapeutic colonoscopies
Country: Spain
Setting: Not stated
Age: Not stated
N (%) males: Not stated
ASA score: Not stated
Groups comparable at baseline: Unclear

Interventions

Group A (n=4,005): Propofol
Group B (n=3,281): Diazepam
Dosage: Not stated
Mode of administration: Not stated, other than that both drugs were given I.V.
Administered by: Not stated
Goal level of sedation: Deep sedation with propofol. Conscious sedation with diazepam.
Supplemental oxygen: Unclear

Outcomes

Incidence of colonic perforations

Notes

It is unclear whether only adult patients were included in the study

Methods

Single center, randomised, controlled trial
1) Allocation concealment: unclear
2) Blinding of patients: Yes
3) Blinding of outcome assessors: Yes
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 60
Drop outs/Withdrawals: 3 (one in each group due to intolerance to the procedure)
Incl. Criteria: Consectutive patients scheduled for elective colonoscopy
Excl. Criteria: 1) Age <18 years 2) Allergy to any study medication 3) Patient desire to have colonoscopy without sedation 4) Pregnancy 5) Inability to complete a questionnaire in English following the procedure
Country: Canada
Setting: Elective colonoscopy (? Outpatients)
Age(mean(SD) ) (yrs): Group A: 45.8 (18.4) Group B: 48.3 (18.2) Group C: 40.9 (15.1)
N males: Group A: 9 Group B: 10 Group C: 9
ASA score: Not stated
Groups comparable at baseline: Yes (age, sex ratio, body weight, baseline oxygen saturation, blood pressure, pulse rate)

Interventions

Group A (n=19: Propofol (Bolus: mean (SD) dose: 1.3 (0.29) mg/kg; Infusion mean (SD) dose:76.5 (30) micro gm/kg/min) and Fentanyl (mean (SD) dose: 2.2 (0.48) micro gm/kg)
Group B (n=19): Diazepam (mean(SD) dose: 0.12 (0.04) mg/kg) and Meperidine: (mean (SD) dose: 2.0 (0.50) mg/kg)
Group C (n=19: Midazolam (mean(SD) dose: 0.07 (0.02) mg/kg) and Fentanyl: (mean (SD) dose: 2.2 (0.56) mg/kg)
For meta‐analysis, the results of group B and C were combined.
Mode of administration: Propofol: bolus and infusion; Other drugs: bolus
Administered by: Not stated
Goal level of sedation: Level 3 or 4 on 5‐point MacKenzie sedation score
Initially all patients breathed room air. Oxygen was administered if SpO2 dropped below 85% for longer than 15 s.

Outcomes

Reliability of sedation
Recovery time
Complications

Notes

Definitions:
1) Recovery time: multiple definitions used in the study (time to eye opening, response to command, orientation, return to level 1 sedation and Aldrete score of 10). We abstracted the time to achieving Aldrete score of 10.
2) Sedation level: adequate or inadequate by endoscopist; assessment by patients was also assessed‐however results are not given for each group separately.
The paper does not mention apnea or requirement of any intervention other increasing oxygen to maintain SpO2.

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Yes
3) Blinding of outcome assessors: Unclear/Not stated
4) A priori calculation of sample size: Yes
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: 166
Number of patients enrolled: 150 (numbers in each group obtained from the first author)
Drop outs/Withdrawals: 0
Incl. Criteria: Consectutive patients scheduled for colonoscopy
Excl. Criteria: 1) Age below 18 or above 75 2) History of colonic resection 3) Allergy to study medication 4) Severe cardiorespiratory disease (ASA class III or higher) 5) Renal or hepatic impairment 6) Seizure disorder 7) Psychiatric disease 8) Substance abuse 9) Pregnancy or breast feeding 10) Refusal to receive any medication for the forthcoming colonoscopy
Country: Switzerland
Setting: Outpatient
Age(median(IQR) )(yrs): Group A: 55 (43‐63) Group B: 55 (40‐65) Group C: 48 (35‐64)
% males: Group A: 56 Group B: 44 Group C: 54
ASA score: I or II
Groups comparable at baseline: Yes (age, sex ratio, education, prior colonoscopy with or without sedation, pre‐colonoscopy anxiety)

Interventions

Group A (n=50): PCS with Propofol (median(IQR) dose: 78 (57‐119) mg) and Alfentanil ( 198 (144‐300) micrograms)
Group B (n=50): Continous infusion of Propofol (median(IQR) dose: 90 (68‐131) mg) and Alfentanil ( 227 (173‐331) micrograms)
Group C (n=50): Midazolam (median(IQR) dose: 2.7 (2.3‐3.0) mg) and Meperidine ( 27(23‐30)mg)
Mode of administration: Groups A and C:bolus Group B: continuous infusion
Administered by: nurse, supervised by endoscopist
Goal level of sedation: Patient comfort
All received supplemental oxygen (2 L/min) through nasal cannula

Outcomes

Primary outcome: patient satisfaction with the degree of sedation during colonoscopy
Secondary outcomes: pain, procedure time, amnesia, safety, recovery

Notes

Definitions:
1) Patient satisfaction with the degree of sedation during colonoscopy: was measured 90 minutes after the procedure on a 10 cm VAS
2) Pain during procedure: 90 minutes after the procedure, patients asked to rate their pain during the procedure on a 10 cm VAS
3) Recovery from sedation: judged by Trieger dot‐joining test before, as well as 15, 45 and 90 minutes after colonoscopy
Data extraction combined for both the propofol groups

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear
2) Blinding of patients: Not stated
3) Blinding of outcome assessors: Unclear/Not stated
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Unclear

Participants

Number of eligible patients: 148
Number of patients enrolled: 94
Drop outs/Withdrawals: 0
Incl. Criteria: Patients with ASA class I or II, who were scheduled to undergo colonoscopy between November 2004 and March 2005
Excl. Criteria: Not stated
Country: France
Setting: Outpatient
Age(mean(SD) )(yrs): Group A: 55.6 (11.2) Group B: 55.3 (11.8)
N (%) males: Group A: 29 (58) Group B: 25(50)
ASA score (mean(SD)): Group A: 1.36 (0.45) Group B: 1.31(0.60)
Groups comparable at baseline: Yes (age, sex ratio, body weight, race, education, alcohol intake, smoking, handedness, prior colonoscopy, ASA score)

Interventions

Group A (n=Not stated): Propofol dose: 94 (30‐210) mg
Group B (n=Not stated): Propofol dose: 260 (60‐670) mg
Mode of administration: Gropu A: bolus; Group B: Intravenous administration with an objective of concentration
Administered by: Group A: endoscopist (gastroenterologist) Group B: anaesthesiologist
Goal level of sedation: Group A: Sedation Group B: Anesthesia
All received supplemental oxygen (5 L/min) through nasal cannula

Outcomes

Primary outcome: Patient satisfaction scores, measured on a VAS, 4 hours after colonoscopy
Secondary outcomes: Patients' level of sedation, acceptance, procedure time, cecal intubation time, episodes of desaturation and hypotension

Notes

Numbers enrolled in each group not provided. Measure of variation and exact p value not provided for average satisfaction scores or procedure times
Definitions:
1) Patients' level of satisfaction scores, measured on a VAS, 4 hours after colonoscopy
2) No other definitions provided

Methods

Single center, randomised, controlled trial
1. Allocation concealment: Unclear/Not stated
2. Blinding of patients: Unclear/Not stated
3. Blinding of outcome assessor: Unclear/Not stated
4. A priori calculation of sample size: Unclear/Not stated
5. Groups treated identical other than the named intervention: Unclear/Not stated

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 110
Drop outs/Withdrawals: 0
Incl. Criteria:Patients undergoing colonoscopy as an out patient between July 1999 and October 1999
Excl. Criteria: Not stated
Country: Hong Kong
Setting: Outpatient
Age: Not stated
N (%) males: Not stated
Groups comparable at baseline: Yes (age, sex ratio and body weight)

Interventions

Group A (n=55): Mixture of Propofol 400 mg and Alfentanil 1mg delivered by a PCA pump in bolus of 2mg/ml (lockout period of 3 minutes)
Group B (n=55): Intravenous injection of Diazemuls 0.1 mg/ Kg and Pethidine 0.5mg/ Kg
Mode of administration: Gropu A: PCA pump bolus, with lockout of 3 mins.; Group B: Intravenous injection
Administered by: Not stated
Goal level of sedation: Not stated
Supplemental oxygen: Not stated

Outcomes

Procedure time; Recovery time
Pain score (un‐scaled 10 cm visual analogue score)
Oxygen desaturation<90%
Hypotension (systolic BP < 90 mm Hg)

Notes

Recovery time not defined
Conference proceeding abstract (DDW 2000)

Methods

Single center, randomised, controlled trial
1. Allocation concealment: Adequate
2. Blinding of patients: Unclear/Not stated
3. Blinding of outcome assessor: No for the primary outcome, as the level of sedation was recorded by the designated nurse responsible for drug delivery (which was not blinded). For other outcomes Unclear/Not stated‐likely no blinding.
4. A priori calculation of sample size: Yes
5. Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: 186
Number of patients enrolled:178
Drop outs/Withdrawals: 0

Incl. Criteria: 1) Patients scheduled for out patient colonoscopy only 2) Age 18‐65 years 3) ASA class I or II
Excl. Criteria: 1) ASA class III or above 2) Pregnancy 3) Allergy to any sedative agents 4) Inpatient status 5) History of colonic or rectal resection 6) Cognitive deficit or intellectual disability 6) History of difficult endotracheal intubation 7) Inability or reluctance to give consent.

Country: Hong Kong
Setting: Outpatient
Age (median(range))(yrs): Group A: 48.5 (20‐64) Group B: 49.5 (18‐65)
N (%) males: Group A: 43 (49) Group B: 55(61)
Groups comparable at baseline: Yes (age, gender, ASA class, previous history of colonoscopy, indications for colonoscopy and baseline hemodynamic parameters)

Interventions

Group A (n=88): Nurse administered propofol sedation. A loading dose of 40‐60 mg or 0.8 mg/kg propofol, whichever was the higher, was given to patients 1 minute before the commencement of the procedure.. Then a PCA pump was used by the designated nurse to deliver a bolus dose of 1,5 ml mixture containing 14.3 mg propofol admixed with 35 microgram of alfentanil, with zero lock‐out for a goal OSSA score of 3 (assessed every 30 seconds). Median (range) dose; propofol 165 mg (52‐292); alfentanil 0.175 mg (0.035‐0.595)
Group B (n=90): Intravenous injection of Diazemuls 0.1 mg/ Kg and Pethidine 0.5mg/ Kg per bolus 1 minute before the commencement of the procedure. Additional drugs administered as half‐dosage bolus, upon request of the endoscopist. Median (range) dose; diazemuls 5 mg (5‐10); pethidine 25 mg (25‐50)
Mode of administration: Group A: PCA pump bolus; Group B: Intravenous bolus injections
Administered by: Five designated nurses
Goal level of sedation: Group A: OSSA 4 Gropu B: as requested by the endoscopist
Supplemental oxygen: All patients received supplemental oxygen (2 L/min) through nasal cannula

Outcomes

The primary end‐point of the study was the patient's level of sedation (measured by OSSA score) during colonoscopy intubation and when the cecum was reached.

Secondary outcomes:

1) Time to cecal intubation and total procedure time

2) Patient, endoscopist and nurse satisfaction scores with regard to sedation

3) Overall pain score

4) Patients' willingness to repeat colonoscopy with the same sedation

5) Complications related to sedation

6) Cost comparison

Notes

Nurses and endoscopists involved in the study were first trained by an anaesthesiologist regarding propofol delivery, patient monitoring using OSSA score and airway management.

Concealment of allocation is judged to be adequate as first written informed consent was obtained and then randomizations carried out by a designated nurse, using computer generated numbers inside concealed envelopes.

Definitions:
1) Patients' level of sedation, measured by OSSA score

2) Complications related to sedation: Hypotension (systolic BP < 90 mm Hg); Oxygen desaturation<90%; Bradycardia (pulse< 50/min).

3) Full recovery= Fully alert (able to calculate serial subtraction in 7s from 100), hemodynamically stable (BP and HR within 20% of baseline and oxygen saturation >90% at room air) and ambulant.

4) Patient, nurse and endoscopist satisfaction: After full recovery of the patient, satisfaction scores regarding sedation from the patient, nurse and endoscopist were documented, using a 10 cm VAS, ranging from 0 (very unsatisfied) to 10 (very satisfied)

5) Pain: as reported by the patients on a similar scale.

The continuous outcome variables (procedure time, recovery time, patient satisfaction, pain score, level of sedation) were reported as median and range. As per the Cochrane collaboration handbook, ranges should not be used to calculate SDs and hence these were not included in the meta‐analyses.

For the review, we extracted the level of sedation as dichotomous outcome, with "failure to sedate" considered as those with OSSA score of 5 during colonoscopy intubation.

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Adequate
2) Blinding of patients: Yes
3) Blinding of outcome assessors: Yes
4) A priori calculation of sample size: Yes
5) Groups treated identical other than the named intervention: Unclear/Not stated

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 50
Drop outs/Withdrawals: 1(noncompliance with bowel preparation)
Incl. Criteria: Patients scheduled for elective outpatient colonoscopy with conscious sedation
Excl. Criteria: Not stated
Country: USA
Setting: Outpatient
Age(mean(SD) )(yrs): Group A: 60.5 (9.6) Group B: 57.7 (10.8)
N (%) males: Group A: 13 (52) Group B: 11(46)

ASA score : Not provided for all patients (ASA score III: Groups A:2 and group B:1)
Groups comparable at baseline: Yes (age, gender, BMI and number of ASA III patients)

Interventions

Group A (n=25): Propofol (10 mg/ml) and Remifentanil (10 micrograms/ml): Initial bolus of 2.5 ml with demand of 0.75 ml at zero lockout Group B (n=24): Midazolam (0.5 mg/ml) and Fentanyl (12.5 micrograms/ml): Initial bolus of 4 ml with demand of 1ml at 1' lockout
Mode of administration: Both groups‐PCS boluses
Administered by: PCS; anaesthesiologist present to intervene
Goal level of sedation: Not stated
All patients received supplemental oxygen (2 L/min) through nasal cannula

Outcomes

Procedure time, time to sedation, recovery time, SaO2 < 85% for 60", patient satisfaction

Notes

Block size of 10 for first ten cases and then 40 for the rest of the cases was used.

No mention, whether the study was performed on adult patients, but the mean age and use of PCS suggests that patients were adults. Anesthesiologist intervention for oxygen desaturation recorded
Definitions:
1) Patient, gastroenterologist and nurse satisfaction was assessed on a 7‐point Likert scale; however the results section does not provide the recorded scores.

2) Recovery time= time to ambulation‐time at removal of colonoscope; however the time reported in the study and abstracted by us is the "recovery room time", which was not explicitly defined in the study.

3) Procedure time=time between colonoscope removal and insertion.

4) Safety endpoints included: arterial desaturation (85% for more than 60 s); hypotension (90 mmHg systolic or 20% decrease from baseline persisting on repeat determination 1 min later )or inability to tolerate the procedure.

5) Time to sedation: time between insertion of the colonoscope and initiation of the sedation.

Methods

Randomized, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Not stated
3) Blinding of outcome assessors: Not stated
4) A priori calculation of sample size: Not stated
5) Groups treated identical other than the named intervention: Unclear/Not stated

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 299
Drop outs/Withdrawals: Unclear
Incl. Criteria: Not stated
Excl. Criteria: Previously difficult and poorly tolerated colonoscopies
Country: Spain
Setting: Unclear
Age(yrs): Not stated
N (%) males: Not stated
ASA score: Not stated. ASA IV patients were included
Groups comparable at baseline: Yes (age, gender, ASA classification, previous experience in colonoscopy and incidence of polypectomy)

Interventions

Group A (n=103): Remiphentanyl (0.1 micrograms/ Kg/min) followed by bolus of Propofol (0.5 mg/ Kg)
Group B (n=109): Phentanyl (100 micrograms) and Midazolam (2 mg)
Group C (n=87): Meperidine (100 mg) and Midazolam (2 mg)
ASA IV patients in group B and C, initially received half the doses.
Mode of administration:Remiphentanyl infusion; Propofol bolus;
Administered by: Group A: Anesthesiologists; Group B and C: endoscopists
Goal level of sedation: Not stated
Administration of supplemental oxygen: Not stated

Outcomes

Procedure time, recovery time, colonoscopy completion rate, endoscopist assessment of procedure difficulty and adequacy of sedation, and patient assessment of sedation.

Notes

Age of patients not given in the abstract.
Definitions:
1) Patient discharge: Ten points on Aldrete test were needed for patient discharge.

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: No
3) Blinding of outcome assessors: No
4) A priori calculation of sample size: Yes
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 40
Drop outs/Withdrawals:1 in remifentanil group
Incl. Criteria: 1) Age: 18‐65 years 2) Outpatients 3) Scheduled for complete colonoscopy
Excl. Criteria: 1) Pulmonary, cardiovascular, hepatic, renal, haematological, neurological or metabolic diseases 2) History of allergic reactions to any of the study drugs 3) Patients chronically receiving opoid analgesics or sedative medication 3) General anaesthesia within 7 days before the study
Country: Belgium
Setting: Outpatient
Age(mean(SD) )(yrs): Group A: 41 (15) Group B: 40 (11)
N (%) males: Group A: 5 (25) Group B: 3(15)
ASA score (I/II): Group A: 16/4 Group B: 18/2
Groups comparable at baseline: Yes (age, sex ratio, body weight, height, indication for colonoscopy, ASA score)

Interventions

Group A (n=20): Propofol (Mean (range) dose: 273 (153‐490) mg)
Group B (n=20): Remifentanil (Mean(range) dose: 246 (125‐460) micrograms)
Mode of administration: Both groups‐bolus, followed by infusion and supplemental doses
Administered by: anaesthesiologist
Goal level of sedation: Group A: Supplemental doses given, when lightening of anaesthesia observed Group B: Supplemental doses given, when patients experienced pain
All received supplemental oxygen (5 L/min) through face mask

Outcomes

Primary outcome: Recovery time
Secondary outcomes: recovery characteristics (neuropsychological test ing scores, before and after the colonoscopy), adverse events (hypoventilation, apnoea, airway obstruction, hypotension, hypertension, dysrhythmias), patient comfort (patient well being 30 mins. after end of anaesthesia, satisfaction with anaesthesia, severe abdominal pain)

Notes

Definitions:
1) Recovery time: immediate recovery assessed using the Steward Post Recovery Score (SPRS)

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: No
3) Blinding of outcome assessors: Yes
4) A priori calculation of sample size: Not stated
5) Groups treated identical other than the named intervention: Not stated

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 29
Drop outs/Withdrawals: 0
Incl. Criteria: Not stated
Excl. Criteria: Not stated
Country: Spain
Setting: Ambulatory colonoscopy
Age(yrs):45‐75
N (%) males: Not stated
ASA score: Not stated
Groups comparable at baseline: Not stated

Interventions

Group A (n=14): Propofol (Mean dose: 191.79 mg)
Group B (n=15): Midazolam (Mean dose: 18.93 mg) and Flumazenil (Mean dose: 0.28 mg). All patients in this group received incremental doses of flumazenil, until awakening
Mode of administration: Both groups‐bolus
Administered by: Not stated
Goal level of sedation: Not stated
Administration of supplemental oxygen: Not stated

Outcomes

Recovery time, discharge time, post procedure amnesia, patient satisfaction, endoscopist satisfaction
Vitals and level of sedation during the procedure also measured

Notes

Abstract DDW 1994
Definitions:
1) Recovery time: time to sit, walk and get dressed measured. Time to get dressed used in the meta‐analysis.
2) Methodology for measuring other outcomes not given

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: No
3) Blinding of outcome assessors: Yes
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 88
Drop outs/Withdrawals: 0
Incl. Criteria: 1) Adult patients scheduled for elective colonoscopy 2) ASA class I or II
Excl. Criteria: 1) Pregnancy 2) Patients assessed as being unable to understand or operate the PCS pump
Country: Singapore
Setting: Patients scheduled for elective colonoscopy
Age(mean(SD) )(yrs): Group A: 54 (15) Group B: 49 (13)
N (%) males: Group A: 27 (61) Group B: 21(48)
ASA score (I/II): Group A: 24/20 Group B: 22/22
Groups comparable at baseline: Yes (age, sex ratio, body weight, ASA score)

Interventions

Group A (n=44): Propofol (Mean (SD) dose: 98.20(36.74) mg)
Group B (n=44): Midazolam (Mean(SD) dose: 4.33 (2.08) mg)
Mode of administration: Both groups‐bolus; propofol given as PCS
Administered by: Group A: PCS Group B: anaesthesiologist
Goal level of sedation: Patients in Group B given additional boluses when they experienced discomfort
All received supplemental oxygen through nasal cannula, if SaO2 fell below 94%

Outcomes

Primary outcomes: Endoscopist satisfaction, patient cooperation, deepest sedation score, sedation score 30 minutes after surgery and time to discharge
Secondary outcomes: Patient overall satisfaction, Patients' level of pain

Notes

1) Discharge time: Patients deemed fit according to existing protocol in endoscopy suite.
2) Sedation: Patients level of sedation measured on a 6 point scale
3) Pain: Nursing staff assessed pain scores 30 minutes after the procedure on a 4 point scale (post operative pain‐‐therefore not included in the meta‐analysis)
4) Patient satisfaction: assessed on a 4 point scale; results expressed as very/ mostly satisfied vs. mildly satisfied/ quite dissatisfied

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Unclear/Not stated
3) Blinding of outcome assessors: No
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 120
Drop outs/Withdrawals: Unclear/Not stated
Incl. Criteria: Consecutive patients who underwent total colonoscopy
Excl. Criteria: 1) Age under 18 or over 80 yrs 2) Cases with incomplete colonoscopy 3) Liver cirrhosis 4) Regular dialysis 5) Critically ill patients (ASA grade V) 6) Pregnant women 7) Cases with chronic use of benzodiazepines or opiates.
Country: Greece
Setting: Unclear/Not stated
Age(mean(SD) )(yrs): Group A: 61.4 (11) Group B: 60.2 (11.5)
N (%) males: Group A: 33 (52) Group B: 29(52)
ASA grade (n (%): < or = II Group A : 52 (81) Group B: 46(82)
> II Group A : 12 (19) Group B: 10(18)
Groups comparable at baseline: Yes (age, sex ratio, ASA grade)

Interventions

Group A (n=64): Propofol (Median (range) dose: 80 (40‐150) mg) and Midazolam ( 2‐3 mg)
Group B (n=56): Midazolam (Median (range) dose: 5 (3‐7) mg) and Pethidine: (Median (range) dose: 75 (50‐125) mg)
Mode of administration: Both groups‐bolus
Administered by: Anesthesiologist
Goal level of sedation: Group A: adequate level of sedation Group B: Given additional boluses of pethidine, if patients did not tolerate the procedure
All received supplemental oxygen (2 L/min) through nasal cannula

Outcomes

Complications (a decline in oxygen saturation <90% for more than 10 s, change in MABP > 10 mm Hg, change in HR < or > 20%)
Patients' level of sedation and pain
Recovery from sedation

Notes

Number of withdrawals is unclear, as only complete colonoscopies were included. There might have been some patients with incomplete colonoscopy, who were withdrawn after enrolment.
Definitions:
1) Recovery from sedation assessed at 5,10,15 and 20 mins., after the procedure, using Aldrete score.
2) Sedation: Patients level of sedation measured on a 5 point scale by anaesthesiologists during procedures and 4 point scale by endoscopists after the procedure
3) Pain: Patients asked (2 hr after the procedure) to rate their pain during the procedure on a 0 to 10 VAS
4) Patient satisfaction: Patients asked (24 hr after the procedure) to rate their evaluation of colonoscopy on a 4 point comfort level scale (data extracted for meta‐analysis dichotomized as No discomfort/Slightly Uncomfortable vs. Extremely uncomfortable/Unacceptable)

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: Yes
3) Blinding of outcome assessors: No
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Unclear/Not stated

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 102
Drop outs/Withdrawals: 3
Incl. Criteria: In‐patients, who were 18 years of age or older
Excl. Criteria: Serious unrelated medical diseases
Country: Germany
Setting: Inpatient
Age(mean)(yrs): Group A: 55 Group B: 62
N (%) males: Group A: 21 (43) Group B: 25(50)
ASA score: Not stated
Groups comparable at baseline: Yes (age, sex ratio)

Interventions

Group A (n=49): Propofol: Initial bolus 2.5 mg/kg body weight (for participants 18‐50 years age), 1.7 mg/kg (51‐74 years) or 1.1 mg/kg (75‐93 years). Subsequent infusion 6 mg/kg/hr (18‐50 years ), 4.5 mg/kg/hr (51‐74 years) or 3.8 mg/kg/hr (75‐93 years)
Group B (n=50): Midazolam: Maximum dose 12.5 mg
Mode of administration: Propofol: bolus followed by infusion Midazolam: bolus
Administration directed by endoscopist
Goal level of sedation: Slurred speech or lack of reaction (no response to verbal commands)
Supplemental oxygen (2 L/min through nasal cannula) administered if oxygen saturation dropped to <90% for more than 1 min

Outcomes

Patients' level of sedation, pain, ability to cooperate, acceptability of procedure, antegrade amnesia, complications (a decline in oxygen saturation, drop in systolic and diastolic pressure, apnea)

Notes

German language article
Patients likely blinded, although not explicitly stated in the study. It was stated that the study was single blinded.
Withdrawals: Data from three patients (2 in propofol group and 1 in midazolam) were not analysed in the study as they had to be given more than the prescribed medications
Definitions:
1) Patients' level of sedation: assessed after the initial bolus injection as awake, somnolent (reaction to verbal command) and asleep
2) Patients' ability to cooperate and acceptability of procedure graded by the endoscopists, immediately after the colonoscopy, on a 10 point scale
3) Pain: Patients asked ( 4 hrs after the procedure) to rate their pain during the procedure on a 10 point scale
4) Mean (and range) drop in systolic, diastolic pressures and O2 saturation provided

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: No
3) Blinding of outcome assessors: Yes for a) examiners who assessed cognitive patterns and recovery time
No for a)endoscopy team
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 79
Drop outs/Withdrawals: 0
Incl. Criteria: Patients admitted for elective, diagnostic colonoscopies
Excl. Criteria: 1) Age less than 18 years or more than 60 years 2) Chronic use of benzodiazepines 3) Known hypersensitivity to midazolam, propofol, or nalbuphine 4) Mental incompetence 5) Pregnancy 6) Severe heart failure 7) Liver cirrhosis 8) Regular dialysis 9) Previous colonic resections
Country: Germany
Setting: Outpatient
Age(mean(SE) )(yrs): Group A: 44 (12) Group B: 41 (12)
(%) males: Group A: 57 Group B: 53
ASA score : Not stated
Groups comparable at baseline: Yes (age, sex ratio, body weight, height, alcohol intake, anxiety level and indications for procedures)

Interventions

Group A (n=47): Propofol (Median (IQR) dose: 100 (53‐145) mg) and initially 2 mg of midazolam
Group B (n=32): Midazolam (Median(IQR) dose: 9 (6‐12) mg) and Nalbuphine: (Median(IQR) dose: 20(10‐20) mg) for the 62%, who did receive nalbuphine
Ketamine allowed in both groups, in cases of poor sedation
Mode of administration: Both groups‐bolus
Administered by: physician trained in critical care medicine
Goal level of sedation: Group A: "adequate sedation level" Group B: patient tolerance of the procedure
Not stated, whether all patients received supplemental oxygen at baseline

Outcomes

Recovery time, Patients' cognitive function (before and after the colonoscopy), procedure time, patient satisfaction, endoscopist assessment of quality of sedation, severe oxygen desaturation (SaO2 <85%), change in BP (MAP), HR or RR

Notes

Although " the study was planned to include 150 patients", no information is provided on the sample size calculation
Definitions:
1) Patient satisfaction:Patients asked (after the procedure) to rate their experience during the colonoscopy: distressing, slightly uncomfortable, or comfortable (results dichotomised as uncomfortable vs. comfortable for meta‐analysis)
2) Recovery time: time to open eyes, speak, shake hands, walk (extracted for meta‐analysis), street fit
3) Fit for discharge: not defined
4) Complications: Determined by monitoring of blood pressure, heart rate and oxygen saturation ; also recorded‐severe oxygen desaturation (SaO2 <85%), "clinically unacceptable changes in BP, HR or RR"

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Unclear/Not stated
2) Blinding of patients: No
3) Blinding of outcome assessors: No
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: 86
Number of patients enrolled: 66
Drop outs/Withdrawals: 0
Incl. Criteria: Consecutive patients undergoing routine day‐case colonoscopy
Excl. Criteria: 1) Age less than 18 years 2) Severe pre‐existing cardiovascular or respiratory disease 3) Those felt to be unable to use the PCS system
Country: UK
Setting: Outpatient
Age(median(range) )(yrs): Group A: 50 52 (23‐74) Group B: (29‐73)
N (%) males: Not stated
ASA score: Not stated
Groups comparable at baseline: Yes (age, body weight, performance of pre‐procedure number connection test)

Interventions

Group A (n=33): PCS Propofol (Median dose: 105 mg) and Alfentanil (Median dose: 0.13 mg)
Group B (n=33): Diazemul (Median (range) dose: 15 (10‐20) mg) and Pethidine: single bolus dose of 50 mg
Mode of administration: Group A: PCS boluses Group B: single bolus at beginning of procedure
Administered by: Group A: PCS Group B: endoscopist; All patients monitored by anaesthetists
Goal level of sedation: Group A (PCS): relieve any discomfort Group B: Not stated
All received supplemental oxygen (2 L/min) through nasal cannula

Outcomes

Procedure time, patients' level of sedation, pain, complications, recovery time, patient satisfaction

Notes

Definitions:
1) Patients' level of sedation, measured by a single nurse specialist during the procedure on a 5 point scale
2) Pain score: Patients' recollection, after recovery on a 4 point scale (also measured by a single nurse specialist during the procedure)
3) Recovery time: measured by comparison of number connection tests (NCTs) completed at 10‐min intervals after completion of the procedure with the NCT undertaken prior to sedation.
4) Complications: Maximum fall in systolic blood pressure, difference in O2 saturation, O2 desaturation less than 95%
5) Overall patient satisfaction: not defined

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Inadequate
2) Blinding of patients: Yes
3) Blinding of outcome assessors: Yes for a) examiners performing the neuropsychological testing and assessing patient wakefulness b) recovery room nurses
No for endoscopists and nurses administrating sedation
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: 82
Number of patients enrolled: 80
Drop outs/Withdrawals: 0
Incl. Criteria: Consectutive patients undergoing colonoscopy as out patients who were 1) 18 years of age or older 2) ASA class I or II 3) Scheduled to undergo colonoscopy alone
Excl. Criteria: 1) Patient desire to have colonoscopy without sedation 2) ASA class III or more 3) History of colonic or rectal resection 4) Sleep apnea 5) Enlarged tongue 6) Inability to widely open the mouth 7) Short thick neck 8) Known delayed gastric emptying 9) Acute gastrointestinal bleeding 10) Any neurological deficit 11) Pregnancy 12) Inability or unwillingness to give consent 13) Inpatient status 14) An allergy to either eggs or soy products or any of the sedative agents
Country: USA
Setting: Outpatient
Age(mean(SD) )(yrs): Group A: 51.7 (11.3) Group B: 54.2 (14.2)
N (%) males: Group A: 21 (52.5) Group B: 19 (47.5)
ASA score (mean(SD)): Group A: 1.25 (0.44) Group B: 1.3(0.46)
Groups comparable at baseline: Yes (age, sex ratio, body weight, race, education, alcohol intake, smoking, handedness, prior colonoscopy, ASA score)

Interventions

Group A (n=40): Propofol (Mean (SD) dose: 214 (94) mg) Bolus administration
Group B (n=40): Midazolam (Mean(SD) dose: 4.7 (1.5) mg) and Meperidine: (Mean (SD) dose: 89.7(29.1)mg)
Mode of administration: Both groups‐bolus
Administered by: nurse, supervised by endoscopist
Goal level of sedation: Nurses instructed to induce a state that allowed patients to tolerate the procedure with minimal to mild pain, while maintaining adequate cardiorespiratory function
All received supplemental oxygen (4 L/min) through nasal cannula

Outcomes

Primary outcomes: sedation time, recovery time, discharge time, patient satisfaction scores (10 cm VAS)
Secondary outcomes: procedure time, patients' level of sedation, pain, ability to cooperate, Complications (a decline in oxygen saturation <85%, HR< 50, BP < 90/50, need for mechanical ventilation), neuropsychological testing scores (before and after the colonoscopy)

Notes

Before starting the study, the sequence of sedation treatments was created with a coin toss and blocks of 4. The block size of 4 may have been too small to prevent deciphering of sequence.
Definitions:
1) Full recovery defined as: systolic/diastolic BP and HR within 20% of baseline, O2 saturation >90% while breathing room air and ability to stand at bedside without instability or assistance
Recovery also defined as time to reach score of 5 on Observer's Assessment of Alertness/Sedation scale (data presented in figure only)
2) Discharge time: Recovery room nurses determined when patients could be discharged. The general criteria were: systolic/diastolic BP and HR within 20% of baseline, O2 saturation >90% while breathing room air, ability to walk without instability and ability to drink liquids
3) Sedation: Patients level of sedation measured on a 5 point scale. Nurses instructed to induce a state that allowed patients to tolerate the procedure with minimal to mild pain, while maintaining adequate cardiorespiratory function
4) Pain: Patients asked (after the procedure) to rate their pain during the procedure: None, Mild, Moderate, Severe. Data abstracted for meta‐analysis as Moderate/Severe Pain vs. No/Mild Pain
5) Patient Satisfaction: Patients completed a satisfaction questionnaire by using a visual 10‐cm analogue scale for "overall satisfaction with colonoscopy procedure"

Methods

Single center, randomised, controlled trial
1) Allocation concealment: Adequate
2) Blinding of patients: Yes
3) Blinding of outcome assessors: Yes for a) examiners performing the neuropsychological testing and assessing patient wakefulness b) recovery room nurses
No for a)endoscopists b) nurses administrating the sedation c) endoscopy technicians d) examiners recording intra procedure time points
4) A priori calculation of sample size: Unclear/Not stated
5) Groups treated identical other than the named intervention: Yes

Participants

Number of eligible patients: Not stated
Number of patients enrolled: 100
Drop outs/Withdrawals: 0
Incl. Criteria: Patients who presented for outpatient colonoscopy and were 1) 18 years of age or older 2) ASA class I or II (unless they were class III on the basis of renal insufficiency alone) 3) Scheduled to undergo colonoscopy alone
Excl. Criteria: 1) Patient desire to have colonoscopy without sedation 2) ASA class III or more (unless they were class III on the basis of renal insufficiency alone) 3) History of colonic or rectal resection 4) Obstructive sleep apnea 5) Anticoagulation 6) Inability to widely open the mouth 7) Short thick neck 8) Known delayed gastric emptying 9) Acute gastrointestinal bleeding 10) Neurological deficit 11) Pregnancy 12) Inability or unwillingness to give consent 13) Inpatient status 14) Known hypersensitivity to any of the study medications or to either soy or egg products
Country: USA
Setting: Outpatient
Age(mean(SD) )(yrs): Group A: 55.6 (11.2) Group B: 55.3 (11.8)
N (%) males: Group A: 29 (58) Group B: 25(50)
ASA score (mean(SD)): Group A: 1.36 (0.45) Group B: 1.31(0.60)
Groups comparable at baseline: Yes (age, sex ratio, body weight, race, education, alcohol intake, smoking, handedness, prior colonoscopy, ASA score)

Interventions

Group A (n=50): Propofol (Mean (SD) dose: 277 (105) mg) Bolus administration
Group B (n=50): Midazolam (Mean(SD) dose: 7.2 (2.6) mg) and Fentanyl: (Mean (SD) dose: 117(30) micrograms)
Mode of administration: Both groups‐bolus
Administered by: nurse, supervised by endoscopist
Goal level of sedation: A state that allowed patients to tolerate the procedure with minimal to mild pain, while maintaining adequate cardiorespiratory function
All received supplemental oxygen (4 L/min) through nasal cannula

Outcomes

Primary outcomes: sedation time, recovery time, discharge time, patient satisfaction scores (10 cm VAS)
Secondary outcomes: procedure time, patients' level of sedation, pain, ability to cooperate, Complications (a decline in oxygen saturation <85%, HR< 50, BP < 90/50, need for mechanical ventilation), neuropsychological testing scores (before and after the colonoscopy)

Notes

Definitions:
1) Full recovery defined as: BP and HR within 20% of baseline, O2 saturation >90% while breathing room air and ability to stand at bedside without assistance
Recovery also defined as proportion of patients reaching a score of 5 on Observer's Assessment of Alertness/Sedation scale, 15 mins after arrival to the recovery area
2) Discharge time: Patients met criteria for full recovery, able to drink fluids and judged subjectively to be stable by recovery room nurse.
3) Sedation: Patients level of sedation measured on a 5 point scale
4) Pain: Patients asked (after the procedure) to rate their pain during the procedure: None, Mild, Moderate, Severe. Data abstracted for meta‐analysis dichotomized as Moderate/Severe Pain vs. No/Mild Pain
5) Patient satisfaction: "overall satisfaction with the colonoscopy procedure" on a 10 cm VAS