跳至主要内容
临床试验/CTRI/2024/06/068273
CTRI/2024/06/068273招募中Phase 3 4

Efficacy of etomidate versus propofol on seizure duration and hemodynamics in patients undergoing modified ECT- a randomised cross over study

NKP Salve institute of medical sciences and research centre and LMH hospital Nagpur1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月14日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
To compare the seizure duration produced with etomidate to that with propofol in patients undergoing modified ECT.

研究概览

简要总结

This study is a randomised, double blind cross over study to compare the effectiveness of two different drugs - etomidate 0.2 mg/kg and propofol 1mg/kg - in terms of seizure duration and hemodynamics in patients undergoing modified electroconvulsive therapy. Either of the drug  depending on the study group, will be use as an anaesthetic agent of induction before the application of electrical stimulus in a total of 80 patients, divided into groups of 40 each and suffering from a range of mental disorders according to ICD 11. This study will be conducted in the department of Anaesthesia at a tertiary care centre in Nagpur.

The primary outcome measure will be the seizure duration measured by a stopwatch and hemodynamic changes - heart rate, systolic and diastolic blood pressure, mean arterial pressure, oxygen saturation and end tidal carbon dioxide levels by a multipurpose monitor

The secondary outcome will be measured in terms of the side effects produced by either of the drugs- pain on injection measured by the VAS scale, nausea, vomiting, postictal agitation , memory deficits measured by the MOCA and MMSE scales .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • This study will be conducted on patients suffering from a mental disorder as per ICD 11 and requiring modified electroconvulsive therapy as per the decision of the consultant psychiatrist.

排除标准

  • This study will be conducted on the following patients: patients with a history of relevant drug allergy.
  • patients who have had prior treatment with ECT.
  • patients with a history of substance abuse with relevant drugs.
  • patients with anticipated difficult airway.

结局指标

主要结局

To compare the seizure duration produced with etomidate to that with propofol in patients undergoing modified ECT.

时间窗: From the time application of stimulus until the subsidence of convulsions, the normal range of convulsions induced being 15-100 seconds

次要结局

  • To compare the effect on haemodynamics produced with Etomidate to that with Propofol in patients undergoing modified ECT, in terms of -(1.Heart rate ,)

研究者

发起方
NKP Salve institute of medical sciences and research centre and LMH hospital Nagpur
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sumita Bhargava

NKP SALVE and institute of medical sciences

研究点 (1)

Loading locations...

相似试验