MedPath

A clinical trail to study the effect of two drugs, propofol and etomidate on blood pressure and heart rate during anesthesia for spinal surgery.

Phase 4
Completed
Conditions
Patients undergoing elective lumbar spinal surgeries
Registration Number
CTRI/2018/03/012447
Lead Sponsor
Bangur Institute of Neurosciences
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
70
Inclusion Criteria

patients posted for elective lumbar spinal surgeries.

Exclusion Criteria
  • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean Arterial Pressurebefore giving premedication, before induction of anesthesia, immediately after induction of anaesthesia, at intubation and 1, 3, and 5 min after intubation
Secondary Outcome Measures
NameTimeMethod
Heart rate, Cardiac output, Bispectral indexbefore giving premedication, before induction of anesthesia, immediately after induction of anaesthesia, at intubation and 1, 3, and 5 min after intubation

Trial Locations

Locations (1)

Bangur Institute Of Neurosciences

🇮🇳

Kolkata, WEST BENGAL, India

Bangur Institute Of Neurosciences
🇮🇳Kolkata, WEST BENGAL, India
SAIKAT NIYOGI
Principal investigator
9831732443
saikatneuro1972@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.