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Cochrane Database of Systematic Reviews

Propofol versus tiopental sódico para el tratamiento del estado epiléptico resistente

Información

DOI:
https://doi.org/10.1002/14651858.CD009202.pub4Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 03 febrero 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Epilepsia

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Hemanshu Prabhakar

    Correspondencia a: Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India

    [email protected]

  • Mani Kalaivani

    Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India

Contributions of authors

  • Conceiving the review: Hemanshu Prabhakar (HP).

  • Co‐ordinating the review: HP.

  • Undertaking manual searches: HP.

  • Screening search results: HP.

  • Organising retrieval of papers: HP.

  • Screening retrieved papers against inclusion criteria: HP.

  • Appraising quality of papers: HP.

  • Extracting data from papers: HP.

  • Writing to authors of papers for additional information: HP.

  • Providing additional data about papers: HP.

  • Obtaining and screening data on unpublished studies: HP.

  • Data management for the review: HP, Mani Kalaivani (MK).

  • Entering data into Review Manager (RevMan 2014): HP.

  • RevMan statistical data: HP, MK.

  • Other statistical analysis not using RevMan: HP, MK.

  • Double entry of data: (data entered by person one: HP; data entered by person two: MK).

  • Interpretation of data: HP, MK.

  • Statistical inferences: HP, MK.

  • Writing the review: HP.

  • Guarantor for the review (one author): HP.

  • Person responsible for reading and checking review before submission: HP, MK.

Sources of support

Internal sources

  • All India Institute of Medical Sciences, New Delhi, India.

External sources

  • National Institute of Health Research (NIHR), UK.

    This review was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Epilepsy Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, National Health Service (NHS) or the Department of Health.

Declarations of interest

  • Hemanshu Prabhakar: None known.

  • Mani Kalaivani: None known.

Acknowledgements

We wish to thank the Cochrane Epilepsy Group for their continuous support in helping us prepare the review. We would like to thank Professor A Rossetti for providing the additional data and information on the included study. We wish to thank the South Asian Cochrane Network and Centre, CMC, Vellore, India, who conducted the workshop at the Prof. BV Moses and ICMR Center for Advanced Research and Training in Evidence‐Informed Healthcare, where this review was completed. We wish to acknowledge Gyaninder Pal Singh and Ashish Bindra who contributed to the original version of this review.

Version history

Published

Title

Stage

Authors

Version

2017 Feb 03

Propofol versus thiopental sodium for the treatment of refractory status epilepticus

Review

Hemanshu Prabhakar, Mani Kalaivani

https://doi.org/10.1002/14651858.CD009202.pub4

2015 Jun 25

Propofol versus thiopental sodium for the treatment of refractory status epilepticus

Review

Hemanshu Prabhakar, Mani Kalaivani

https://doi.org/10.1002/14651858.CD009202.pub3

2012 Aug 15

Propofol versus thiopental sodium for the treatment of refractory status epilepticus

Review

Hemanshu Prabhakar, Ashish Bindra, Gyaninder Pal Singh, Mani Kalaivani

https://doi.org/10.1002/14651858.CD009202.pub2

2011 Jul 06

Propofol versus thiopental sodium for the treatment of refractory status epilepticus

Protocol

Hemanshu Prabhakar, Ashish Bindra, Gyaninder Pal Singh, Mani Kalaivani

https://doi.org/10.1002/14651858.CD009202

Differences between protocol and review

The primary outcome in our protocol 'total control of seizures' is now defined as total control of seizures after the first course of the study drug.

By 'mortality' we now mean only in‐hospital mortality of the patients receiving study drugs. It does not include deaths after patients have been discharged from hospital.

A Google Scholar database search has not been conducted and so it has been removed from the list.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adult; Humans;

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.

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Study flow diagram.
Figuras y tablas -
Figure 2

Study flow diagram.

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Comparison 1 Propofol versus thiopental sodium, Outcome 1 Total control of seizures.
Figuras y tablas -
Analysis 1.1

Comparison 1 Propofol versus thiopental sodium, Outcome 1 Total control of seizures.

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Comparison 1 Propofol versus thiopental sodium, Outcome 2 In‐hospital mortality.
Figuras y tablas -
Analysis 1.2

Comparison 1 Propofol versus thiopental sodium, Outcome 2 In‐hospital mortality.

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Comparison 1 Propofol versus thiopental sodium, Outcome 3 Adverse events.
Figuras y tablas -
Analysis 1.3

Comparison 1 Propofol versus thiopental sodium, Outcome 3 Adverse events.

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Study

Propofol group

Thiopentone sodium group

Rossetti 2011

Median: 4 days

Median: 17 days

Rossetti 2011

Range: 2 to 28 days

Range: 5 to 70 days

Figuras y tablas -
Analysis 1.4

Comparison 1 Propofol versus thiopental sodium, Outcome 4 Duration of mechanical ventilation.

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Comparison 1 Propofol versus thiopental sodium, Outcome 5 Long‐term outcomes.
Figuras y tablas -
Analysis 1.5

Comparison 1 Propofol versus thiopental sodium, Outcome 5 Long‐term outcomes.

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Summary of findings for the main comparison. Propofol compared to Thiopental sodium for the treatment of refractory status epilepticus

Propofol compared to Thiopental sodium for the treatment of refractory status epilepticus

Patient or population: patients with the treatment of refractory status epilepticus
Settings: Hospital based
Intervention: Propofol
Comparison: Thiopental sodium

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Thiopental sodium

Propofol

Total control of seizures

Study population

RR 1.5
(0.4 to 5.61)

21
(1 study)

⊕⊕⊝⊝
low1,2

286 per 1000

429 per 1000
(114 to 1000)

In‐hospital mortality

Study population

RR 1.5
(0.19 to 11.93)

21
(1 study)

⊕⊕⊝⊝
low1,2

143 per 1000

214 per 1000
(27 to 1000)

Length of intensive care unit (ICU) stay

Not reported

Not reported

NA

NA

NA

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Single blinded study: we downgraded one level for risk of bias
2 Wide confidence intervals crossing the line of "no effect" were noted; we downgraded one level for imprecision

Figuras y tablas -
Summary of findings for the main comparison. Propofol compared to Thiopental sodium for the treatment of refractory status epilepticus
Ir a la tabla de la revisión
Table 1. Overview of study populations

Study ID

Interventions

Screened (n)

Randomised (n)

Safety analysis (n)

ITT (n)

Finishing study (n)

[%] of randomised participants
finishing study

Rossetti 2011

I1 Propofol

I2 Barbiturate (thiopental (n = 7) and pentobarbital (n = 3))

I1 14

I2 10

I1 14

I2 10

I1 14

I2 10

I1 14

I2 10

I1 14

I2 9

I1 100

I2 90

I1: intervention 1; I2: intervention 2; ITT: intention‐to‐treat; n: number.
Figuras y tablas -
Table 1. Overview of study populations
Ir a la tabla de la revisión
Table 2. Adverse effects

Characteristic

Rossetti 2011

I1

I2

Propofol

Thiopental

Participants who died (n)

Epilepsy‐related

I1 Propofol

I2 Thiopental

0

0

Participants who died (n)

All causes

I1 Propofol

I2 Thiopental

3

1

Adverse events (n)

I1 Propofol

I2 Thiopental

14

11

Serious adverse events (n)

I1 Propofol

I2 Thiopental

1

1

Duration of ICU stay

Not reported

Duration of mechanical ventilation (median (range))

I1 Propofol

I2 Thiopental

17 days (5 to 70 days)

4 days (2 to 28 days)

Duration of hospitalisation

Not reported

Neurological deficits

Not reported

Cognitive deficits

Not reported

Haematological toxicity

Not reported

Liver toxicity

Not reported

Hypersensitivity or drug allergy

Not reported

Bronchopneumonia

Not reported

Other side effects

Not reported

I1: intervention 1; I2: intervention 2; ICU: intensive care unit; n: number.
Figuras y tablas -
Table 2. Adverse effects
Ir a la tabla de la revisión
Comparison 1. Propofol versus thiopental sodium

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total control of seizures Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2 In‐hospital mortality Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Infection

1

21

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.35, 1.41]

3.2 Hypotension

1

21

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.38, 2.00]

3.3 Other serious complications

1

21

Risk Ratio (M‐H, Fixed, 95% CI)

0.5 [0.04, 6.86]

4 Duration of mechanical ventilation Show forest plot

Other data

No numeric data

5 Long‐term outcomes Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Figuras y tablas -
Comparison 1. Propofol versus thiopental sodium
Ir a la tabla de la revisión