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Propofol and bradycardia: causation, frequency and severity
M R Tramèr1, R A Moore, H J McQuay
1Nuffield Department of Anaesthetics, Oxford Radcliffe Hospital, Headington.
British Journal of Anaesthesia
|June 1, 1997
Summary
Propofol anesthesia increases the risk of bradycardia, asystole, and death. This risk is significant in pediatric patients and warrants careful monitoring during propofol use.
Area of Science:
- Anesthesiology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Propofol is a widely used anesthetic agent.
- Adverse events associated with propofol require thorough investigation.
- Understanding the risk of bradycardia with propofol is crucial for patient safety.
Purpose of the Study:
- To investigate the risk of bradycardia, asystole, and death associated with propofol use.
- To systematically review and analyze evidence regarding propofol-induced bradycardia.
Main Methods:
- Conducted a systematic search for published and unpublished reports on propofol and bradycardia.
- Performed quantitative and qualitative analyses of data from various sources, including clinical trials and spontaneous reports.
- Calculated number-needed-to-harm (NNH) for bradycardia and asystole.
Main Results:
- Propofol significantly increased the risk of bradycardia compared to other anesthetics (NNH 11.3).
- In pediatric strabismus surgery, the NNH for bradycardia was 4.1.
- Asystole occurred in 1 in 660 patients; bradycardia-related death risk was 1.4 per 100,000.
Conclusions:
- Propofol carries a finite risk of bradycardia with potential for major harm.
- Systematic data search, not limited to randomized controlled trials, is essential for studying adverse events.
- Findings highlight the need for vigilance and risk management strategies during propofol anesthesia.