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临床试验/CTRI/2024/03/063890
CTRI/2024/03/063890进行中(未招募)不适用

A comparative study of etomidate versus thiopentone for modified electroconvulsive therapy

Institute of Neurosciences Kolkata1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
34
试验地点
1
主要终点
Duration of seizure activity

研究概览

简要总结

Anesthesia during modified electroconvulsive therapy(MECT) is a complex procedure due to the goal of exciting the brain into a seizure immediately after sedation has been induced. The practice varies in centers worldwide and the optimal method for  MECT related anesthesia still remains unclear. Thiopentone and Etomidate are two commonly used agents for MECT. Thiopentone a short acting barbiturate has been a longstanding choice for MECT due to it’s rapid onset and short duration of action, however it may cause dose dependent decrease in systemic vascular resistance, stroke volume and cardiac output leading to compensatory tachycardia making it unsuitable for patients with hemodynamic instability. Etomidate a non-barbiturate hypnotic has emerged as a potential alternative to thiopentone. It exhibits rapid onset , short duration of action and hemodynamic stability during the procedure. Etomidate possesses a favorable side effect profile making it suitable for patients with comorbidities or sensitivity to certain drugs.

Thiopentone and Etomidate are commonly used anesthetics for MECT, however there is a lack of consensus on which anesthetic is most appropriate for the procedure in terms of safety, efficacy and patient outcomes. Therefore the aim of the study is to compare the efficacy and safety of Thiopentone and Etomidate for MECT.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • i) Patients between 18 to 65 years of age posted for modified electroconvulsive therapy.
  • iii) Either sex.

排除标准

  • i)Patients with a history of adverse reactions to either thiopentone or etomidate, ii) Patients with a history of cardiovascular, respiratory, neurological disease or electrolyte imbalance iii)Severe arterial hypertension iv)ASA 3,4.

结局指标

主要结局

Duration of seizure activity

时间窗: Onset of visible contractions to end of visible contractions

次要结局

  • Time to recovery of consciousness and orientation
  • Cardiovascular and respiratory parameters (heart rate, blood pressure, oxygen saturation)
  • Time to recovery of consciousness and orientation(N/A)
  • Adverse effects such as nausea, vomiting, headache, and myoclonus(Anytime in the first 12 hours after ECT.)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Rishanabh Pal

Institute of Neurosciences, Kolkata

研究点 (1)

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