跳至主要内容
临床试验/CTRI/2025/07/090650
CTRI/2025/07/090650尚未招募不适用

A Comparative Study between low dose Ketamine and low dose Propofol for the reduction of myoclonus caused by Etomidate as an induction agent.

SADHARIYA MONA DIPAKBHAI1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2025年7月31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
99
试验地点
1
主要终点
Incidence and Severity of Myoclonus following Etomidate administration

研究概览

简要总结

Etomidate is a short-acting intravenous anesthetic agent used primarily for the induction of general

anesthesia and sedation for short procedure. Etomidate works by enhancing the activity of

gamma-aminobutyric acid (GABA) at the GABA A receptors, which are inhibitory neurotransmitters

in the brain. This results in central nervous system depression and sedation. Although Etomidate is

widely preferred due to its minimal cardiovascular and respiratory stability, one of its notable side

effects is myoclonus,especially during the induction phase of anaesthesia . Etomidate

induced myoclonus refers to involuntary,brief,jerky muscle movements that can occur after the

administration of Etomidate.

The exact cause of Etomidate induced myoclonus is not fully understood but it is thought to be related to the

disinhibition of subcortical structures that are normally suppressed by the brain, resulting in

transient,uncoordinated muscle activity.Myoclonus can lead to damage of muscle fibers, myalgia,

patient discomfort and can also be detrimental in patients with low cardiac reserve.

Etomidate induced myoclonus can be managed by premedicating with other agents like Dexmedetomidine,

Midazolam,Low dose Ketamine,Gabapentin,Dezocine,Magnesium sulfate,Opioids .Low dosePropofol and

low dose Ketamine are two such agents that have been studied for their efficacy in reducing Etomidate-induced myoclonus.

Here is a comparison of the two:Propofol is a sedative-hypnotic agent that works by enhancing GABA A receptor activity,

leading to increased inhibitory neurotransmission and Ketamine is an NMDA receptor antagonist that provides analgesia

and sedation by blocking excitatory neurotransmission . Therefore our aim for this study is to conpare the low dose

Ketamine and low dose Propofol for the reduction of myoclonus caused by Etomidate as an induction agent.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patients Scheduled For Elective Surgeries Requiring General Anaesthesia with ASA I and II.

排除标准

  • Known Allergy or Contraindication to Ketamine , Propofol and Etomidate or History of Epilepsy or other Seizure Disorders or Pregnant or Breast Feeding women or ASA III , IV and V or Patients on chronic sedative or analgesic medication.

结局指标

主要结局

Incidence and Severity of Myoclonus following Etomidate administration

时间窗: Baseline, 1 min,2 min ,3 min ,5 min ,10 min, 15 min, 30 min ,45 min ,1 hr, 1hr 30 min , 2 hr,Post op Immediate,Post op 1 hr

次要结局

未报告次要终点

研究者

发起方
SADHARIYA MONA DIPAKBHAI
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

SADHARIYA MONA DIPAKBHAI

BJ MEDICAL COLLEGE AHMEDABAD

研究点 (1)

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