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临床试验/CTRI/2024/11/077205
CTRI/2024/11/077205尚未招募不适用

To evaluate and compare effects of remifentanil and fentanyl on seizure duration , recovery parameters and degree of stimulus amplitude in patients undergoing modified electroconvulsive therapy

Dr Nishith Govil ,Professor Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Duration of seizure induced

研究概览

简要总结

Modified electroconvulsive therapy (ECT) is commonly used for treatment of depression, mania and affective disorders (1). The mechanism of action is not clearly understood but seizures are necessary for a therapeutic response (2). Prolonged seizures may be more efficacious (3) and a motor seizure duration of greater than 25 s has been recommended to ensure clinical adequacy of treatment (4). Cognitive side-effects and the duration of the period of disorientation are no more prominent with increased seizure duration but rather correlate to the amount of electrical stimulation and electrode placement used during treatment (5-7).

General anesthesia is used during ECT (8). Since most short-acting anaesthetics have anticonvulsant effects, they can increase the threshold and inhibit spread of the seizure, thus modifying the seizure activity and shortening its duration (9).

Fentanyl is a rapid-acting opioid with a moderate duration of action and has no known anticonvulsant effect. Combining fentanyl with propofol produces loss of consciousness with a smaller induction dose of propofol and thus could potentially increase seizure duration (10). Fentanyl is widely used as analgesic in ECT anesthesia because of characteristics such as minimal postoperative confusion and a lower incidence of hypertension or tachycardia during induction of anesthesia.

Remifentanil is a potent ultra short-acting opioid and has no known anticonvulsant effect. Recently, administration of remifentanil in combination with propofol was reported to increase the duration of seizure activity in patients undergoing ECT (5).

The goal of this study was to evaluate and compare effects of remifentanil and fentanyl on seizure duration, recovery parameters and degree of stimulus amplitude in patients undergoing ECT.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Patients suffering with major depressive disorder , psychosis or bipolar disorder.

排除标准

  • Patients having heart diseases, unregulated hypertension, endocrinologic disorders and allergic to test drugs.

结局指标

主要结局

Duration of seizure induced

时间窗: time from electrical stimulus to cessation of tonic clonic motor activity

次要结局

  • hemodynamic parameters, recovery profile and adverse events(induction time to comprehension time and after procedure)

研究者

发起方
Dr Nishith Govil ,Professor Department of Anaesthesiology
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ajay Malik

Shri Guru Ram Rai Institute Of Medical And Health Sciences, dehradun

研究点 (1)

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