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临床试验/CTRI/2026/03/106791
CTRI/2026/03/106791尚未招募不适用

A randomized comparitive study to compare the efficacy of Bispectral Index Monitoring (BIS) with conventional monitoring on consumption of isoflurane and recovery profile in general anaesthesia

Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月5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
60
试验地点
1

研究概览

简要总结

A comparison between Bispectral Index monitoring and conventional monitoring on consumption of Isoflurane and recovery profile in general anaesthesia  a prospective randomized observational study.

Objective

To evaluate the effectiveness of BIS monitoring in maintaining optimal depth of anesthesia compared to conventional clinical monitoring methods

1 To compare the effectiveness of BIS monitoring with conventional monitoring for incidence of intraoperative awareness

2 To compare consumption of volatile anaesthetic agent Isoflurane between BIS monitored and conventionally monitored patients

3 To determine differences in recovery profiles including time to open the eyes following verbal command and extubation and Post Anaesthesia Care Unit stay

4 To examine whether BIS monitoring leads to improved hemodynamic stability during surgery compared to conventional monitoring

5 To explore the overall safety and clinical utility of BIS monitoring as an adjunct to standard anesthetic care

Inclusion criteria

1 Patients of ages 18 to 60 years who gave their consents

2 ASA Grades I and II were selected for study after ethical committee approval

3 Patients undergoing elective general surgical procedures expected to last at least one hour under general endotracheal anaesthesia such as laparotomy cholecystectomy hemithyroidectomy procedures were included in the study

Exclusion criteria

1 Patient refusal to participate in study

2 ASA grade III or higher

3 Patients with known neurologic disease

4 Patients with cardiovascular or metabolic diseases

5 Patients with impaired renal or hepatic function

6 Patients with history of alcohol or drug abuse

7 Patients with psychiatric illness

We will be conducting this on 60 adults aged between 18 to 60 years belonging to grade I and II of American Society of Anesthesiologists classification who will undergo elective surgeries under general anesthesia They will be divided into 2 equal groups randomly

GROUP B monitoring of depth of anaesthesia and titration of inhalational agent Isoflurane is done using BIS monitor

GROUP C Conventional monitoring methods used to assess anesthetic depth such as Clinical signs like movement tearing sweating and hemodynamic parameters like heart rate and blood pressure and end tidal CO2 concentrations

Intraoperatively Pulse Rate Blood Pressure SpO2 will be recorded at 10 minute intervals till the end of surgery BIS monitoring will be done in group B every 10 minutes till extubation

In group C concentrations of the volatile anesthetics will be adjusted according to standard clinical practice which will be to maintain hemodynamic stability and avoid patient movement with the aim of achieving surgical plane of anaesthesia and a rapid recovery after surgery

In group B the volatile anesthetics will be titrated to maintain a BIS value between 40 to 60 A BIS value between 40 to 60 is ideal for surgical plane of anaesthesia and is set as the target for titrating the volatile anaesthetics in group B

All patients will be mechanically ventilated to maintain an end tidal carbon dioxide concentration of 35 to 45 mmHg All inhaled anesthetics will be discontinued on completion of the skin closure and reversal will be done using Inj Glycopyrrolate and Inj Neostigmine intravenously at the end of surgery

In Conventional group extubation will be done based on clinical signs which is spontaneous breathing obeying commands and adequate tidal volume and duration of anaesthesia and surgery will be recorded

In BIS monitoring group required volatile anaesthetic will be recorded and requirement of Isoflurane will calculated by using EHRENWORTH AND EISENKRAFT formula

Site of Study

Department of Anesthesiology

Dhiraj Hospital

SBKS Medical Institute and Research Centre

Piparia

Waghodia

Vadodara

Study Design

Prospective randomized observational comparitive study

Study Duration

The study will be initiated after obtaining permission from institutional ethics committee till the achievement of the sample size or by 18 months whichever is earlier

Likely outcome

This randomized comparative study will help us to compare the efficacy between Bispectral index monitoring and Conventional monitoring in decreasing inhalational agent requirement and maintaining adequate depth of anaesthesia and early recovery from anaesthesia and lesser postoperative stay in PACU

研究设计

研究类型
Observational

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 Grades I and II were selected for study after ethical committee approval.
  • Patients undergoing elective general surgical procedures expected to last at-least one hour under general endotracheal anaesthesia such as laparotomy, cholecystectomy, hemi-thyroidectomy procedures were included in the study.

排除标准

  • Patient refusal to participate in study
  • ASA grade III or higher
  • Patients with known neurologic disease
  • Patients with cardiovascular or metabolic diseases
  • Patients with impaired renal or hepatic function
  • Patients with history of alcohol or drug abuse
  • Patients with psychiatric illness.

研究者

发起方
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Saloni Shah

Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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