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临床试验/CTRI/2018/03/012447
CTRI/2018/03/012447已完成4 期

A comparison of haemodynamic effects between induction agents propofol and etomidate in patients undergoing lumbar spinal surgeries

Bangur Institute of Neurosciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年3月6日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Mean Arterial Pressure

研究概览

简要总结

It was a parallel group, double blind, randomised controlled study wherethe goal was to compare the haemodynamic effects of Propofol and Etomidate asinduction agents in lumbar spine surgeries. 70 patients of ASA Grade I & II of either sex, agedbetween 20 to 65years undergoing elective lumbar spine surgery undergeneral anesthesia were randomly divided into two groups: Group P received BISguided infusion propofol @ 0.5 mg/kg/min and group E received BIS guidedinfusion etomidate @0.05mg/kg/min. Heart rate(HR), oxygen saturation (Spo2),mean arterial pressure(MAP), cardiac output(CO), stroke volume variation(SVV)were measured at preoperative baseline level, before giving premedication, atinduction, intubation, then at 1 min, 3mins & 5 mins following intubation.

 Demographic profilesand baseline parameters of the patients with regards to HR, MAP, CO, SVV, Spo2and BIS of the patients of both the groups were comparable.

 Till intubation HR, COand MAP were decreased in both the groups but the fall was sharper in P group.1min following intubation, there was transient rise in all these parameterswhich came down around baseline in P group but remained at higher level in Egroup following 3 & 5 mins after intubation. Rescue drugs were required incase of E group subjects. SVV was not affected by study drugs.

Based on the results derived from this study, it can beconcluded that when we compared Propofol & Etomidate for BIS guidedinduction in lumbar spine surgeries, the hemodynamic surge with etomidatelasted for a longer period, whereas, in propofol group hemodynamic status wasmaintained within normal range. So, we can say, though, etomidate is a superiorinduction agent in cardiac surgeries, role of etomidate as induction agent inspinal surgery is debatable & not cost effective.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • patients posted for elective lumbar spinal surgeries.

排除标准

  • Children Patients with known significant cardiac, respiratory, hepatic, renal, neurological diseases.
  • Patient refusal .
  • Haematological or endocrinal disorder.
  • Known allergy to study drugs.
  • Psychiatric disease.
  • History of drug abuse.
  • Mallampati Grade 3&4.

结局指标

主要结局

Mean Arterial Pressure

时间窗: before giving premedication, before induction of anesthesia, immediately after induction of anaesthesia, at intubation and 1, 3, and 5 min after intubation

次要结局

  • Heart rate, Cardiac output, Bispectral index(before giving premedication, before induction of anesthesia, immediately after induction of anaesthesia, at intubation and 1, 3, and 5 min after intubation)

研究者

发起方
Bangur Institute of Neurosciences
申办方类型
Government medical college

研究点 (1)

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