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临床试验/NCT04921046
NCT04921046已完成4 期

Effect of Pretreatment of Lignocaine Versus Midazolam in the Prevention of Etomidate Induced Myoclonus

Rawalpindi Medical College0 个研究点目标入组 224 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
224
主要终点
Occurrence and Frequency of Myoclonus

研究概览

简要总结

This study is a randomized control trial and it was conducted to compare the effectiveness of pretreatment with lignocaine versus midazolam on the frequency of myoclonus associated with etomidate induction.

This was conducted in Holy Family Hospital Rawalpindi in a period of 6 months.

详细描述

INTRODUCTION:

General anaesthesia is loss of consciousness induced after administration of one or more general anaesthetic agent with overall aim of inducing sleep, amnesia, analgesia and skeletal muscles relaxation. Choosing an induction agent is a very vital step in commencing general anaesthesia1. Use of sedatives can prevent or minimize potentially harmful physiologic affects of airway manipulation that include increase in heart rate, BP, and raised intracranial pressure.

Etomidate, imidazole-derived, sedative-hypnotic agent, blocks neuroexcitation by its direct action on the gamma amino butyric acid (GABA) receptor complex1.Because of its many desirable properties like rapid onset of action, profound hypnosis, minimal histamine release, hemodynamic stability, minimal respiratory depression, and favorable cerebral effects, etomidate is considered as an ideal induction agent2. Concerns with etomidate include adrenal suppression and myoclonus3, 4.

30 to 60% of unpremedicated patients develop myoclonic movements after an induction dose (0.3 mg/kg) of etomidate1. Myoclonus is described as the involuntary contraction of some muscle fibers, leading to short observable movements of the body, more pronounced with the limbs5. In emergency scenarios, myoclonus can lead to increment in the chances of regurgitation and aspiration.

Various drugs like Lignocaine, Midazolam, Magnesium, Dezocine and dexmedetomidine have been used as pretreatment for reducing myoclonus after etomidate injection but the best drug for the purpose is yet to be discovered6, 7, 8, 9. Ideally a pretreatment drug should be short-acting, should affect respiration and hemodynamic minimally, and should not prolong the recovery period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The test solutions were prepared in coded syringes and the observer was blinded to the groups as well as drugs .

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA-I / ASA-II
  • any gender >20-45 years
  • undergoing elective surgical procedure.

排除标准

  • Patient who refused
  • those with any neurological or psychiatric disorders
  • morbid obesity
  • drug allergies
  • pregnant patients

研究组 & 干预措施

Group Lignocaine

Active Comparator

Group of 112 patients ASA-I and II (American Society of Anesthesiology)ages from 25-44 undergoing elective surgical procedure.

干预措施: lignocaine (Drug)

Group Midazolam

Active Comparator

Group of 112 patients ASA-I and II ages from 25-44 undergoing elective surgical procedure.

干预措施: Midazolam 1 milligram Prefilled Syringe (Drug)

结局指标

主要结局

Occurrence and Frequency of Myoclonus

时间窗: 60 seconds after giving etomidate dose.

involuntary contracting muscle fibers leading to short observable movements more pronounced with the limbs measured by observation by an observer.

次要结局

未报告次要终点

研究者

发起方
Rawalpindi Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

FIZZA BATOOL

Post graduate trainee Anesthesiology

Rawalpindi Medical College

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