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临床试验/CTRI/2023/08/056304
CTRI/2023/08/056304尚未招募不适用

Clinical efficacy of Propofol and Etomidate in Electroconvulsive therapy

Not Applicable1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To evaluate the effects of propofol & etomidate in attenuation of the stress response, induction time, seizure duration, & recovery time during ECT.

研究概览

简要总结

·  Electroconvulsive therapy also known as ECT is used in the treatment of severe psychiatric disorders such as bipolar mood disorders, schizophrenia, catatonic psychosis, and delirium and non-responders of pharmacological therapy.

·   It involves induction of a seizure as a therapeutic method by the administration of a variable frequency electric stimulus, applied through electrodes to the scalp.

·  ECT can produce severe disturbance in the cardiovascular system and a marked increase in cerebral blood flow and intracranial pressure. These changes may be altered using various anaesthetic drugs.

·   Certain anaesthetic agents on account of their anticonvulsant properties have a negative impact on motor seizure duration. Etomidate and Propofol being devoid of the strong anticonvulsant property may be beneficial for use in ECT.

·  The goal of anaesthetic agents in ECT is to get an unconscious patient with muscle paralysis and amnesia and to decrease its hyperdynamic response.

·   Propofol is an ultra-short-acting intravenous induction agent with some favorable properties like smooth induction, quick recovery, and antiemetic properties. It is deemed not a suitable agent in patients with cardiovascular instability and shock as it decreases blood pressure, cardiac output, and systemic vascular resistance due to inhibition of sympathetic vasoconstriction and impairment of the baroreceptor reflex regulatory system

·   Etomidate is one of the induction agents which is claimed to be cardiostable and had gained a lot of popularity in the past and fell out of use due to adrenocortical suppression. Further studies in recent years on etomidate have yielded promising results and it has regained its popularity as a safe anaesthetic and more so in sepsis and hemodynamically unstable and critically ill patients

·   For ECT purpose adequate seizure duration should last around 25-30 seconds

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Age group 18-60 years 2.Patients of both SEX 3.ASA Grade 1&2.

排除标准

  • Patient refusal Patients aged below 18 and above 60 years Patients with risk of aspiration Cardiovascular disease Neuromuscular problems Major sicknesses like Bronchial asthma and Tuberculosis Patients with implants Pregnancy Drug allergy.

结局指标

主要结局

To evaluate the effects of propofol & etomidate in attenuation of the stress response, induction time, seizure duration, & recovery time during ECT.

时间窗: Immediately after induction till 10 min after procedure

次要结局

  • To observe the occurance of any side effects & complications of ECT.(To observe the occurrence of any side effects and complications related to propofol and etomidate.)

研究者

申办方类型
Other [Not Applicable]

研究点 (1)

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