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临床试验/CTRI/2024/09/073405
CTRI/2024/09/073405尚未招募2/3 期

Comparative study between Thiopental and Etomidate on Haemodynamic characteristics during Modified Electroconvulsive Therapy.

HIND INSTITUTE OF MEDICAL SCIENCES SITAPUR1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年9月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
To compare the effect of Thiopental and Etomidate on hemodynamic changes during ECT

研究概览

简要总结

Electroconvulsive therapy (ECT) employs an electric current to generate a generalized cerebral seizure under controlled conditions by electrically stimulating one or both the cerebral hemispheres. The indications for the ECT use include: “severe depression, patients with schizophrenia, schizoaffective disorder, catatonia, neuroleptic malignant syndrome, and bipolar disorder”, etc. It was introduced in the year 1937 by Celletti and Bini. It is generally done under intravenous sedation or general anaesthesia. The primary objective of the anaesthesia during ECT is to keep the haemodynamic and related complications under control. The other associated objectives are to ensure the primary requirements of amnesia and muscle relaxation. the anaesthesia must be optimum enough to suppress the potentially dangerous cardiac and/or central nervous system responses without affecting the treatment Efficacy.

AIM AND OBJECTIVES

This study was undertaken to compare the effects of Intravenous [IV] Sodium ThiopentoneandEtomidate used as IV anesthetic agents in Modified ECT as regards, Haemodynamic changes, duration of clinical seizure and adverse drug reactions between Thiopental and Etomidate.

MATERIALS AND METHODS

A total of 110  patients in the age group of 18-60 of either sex, ASA I/II Patients scheduled to undergo ECT for various indications and haemodynamically stable at the time of ECT were divided randomly into two equal groups.  Group E (n=55) –received 0.2 mg/kg Etomidate (0.2%) injected intravenously over 30 to 60 seconds. Group T (n=55) received 4 mg/kg (2.5%) Thiopental sodium injected intravenously over 30 to 60 seconds.All the patients were monitored for changes HR, SBP, DBP, MAP and SpO2 at baseline and after induction every minute for 15min and after that every 2 min till recovery of ECT. Duration of recovery was recorded from injection of anaesthetic agent to time taken to obey vocal commands such as opening of eyes, tongue protrusion, head lift, finger grasping. Adverse drug reactions, if any were also be noted. In post procedure room, patient was followed for next 60 minutes.

CONCLUSION:

We found that Etomidate offers superior hemodynamic stability during induction compared to Thiopentone. Etomidate  had definite advantage of longer seizure duration compared to Thiopentone.However, it was associated with myoclonic jerks during induction.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • ASA 1 and 2 patients scheduled to under go ECT for various indications .
  • Hemodynamically stable at the time of ECT.

排除标准

  • Patients refused to participate in the study Allergy to trial drugs.

结局指标

主要结局

To compare the effect of Thiopental and Etomidate on hemodynamic changes during ECT

时间窗: 18 months

次要结局

  • To compare the effect of Thiopental and Etomidate with respect to duration of clinical seizure(To compare the recovery time between Thiopental and Etomidate)

研究者

发起方
HIND INSTITUTE OF MEDICAL SCIENCES SITAPUR
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR ROSAMMA K J

Hind Institute of Medical sciences sitapur

研究点 (1)

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