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临床试验/CTRI/2026/01/101011
CTRI/2026/01/101011尚未招募不适用

Comparative study of Bispectral Index Guided Vs Standardised Anaesthesia Management on early Post Operative Recovery in elderly patients undergoing prolonged laparoscopic surgeries

Mahatma Gandhi Medical College And Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年1月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
72
试验地点
1

研究概览

简要总结

One of the most crucial, yet modifiable, factors influencing postoperative outcomes is

the depth of anaesthesia. Traditional methods of estimating anaesthetic depth, based

on haemodynamic parameters and clinical signs, may sometimes be inadequate or

misleading in elderly patients due to blunted autonomic responses or age related

altered pharmacodynamics.

The Bispectral Index BIS monitor provides a quantitative, objective, real time

measure of the patient’s level of consciousness and helps titrate adequate depth of

anaesthesia, by analysing the Electroencephalogram EEG. BIS values range from 0

no brain activity to 100 fully awake, with optimal general anaesthesia depth

typically maintained between 40 and 60. Hence BIS monitoring helps avoid both

excessively deep as well as light levels of sedation causing awareness and stress

related complication.

In elderly patients, over sedation is particularly harmful, often leading to delayed

emergence, hypotension, post operative cognitive impairment, in the form ofPost

Operative Delirium, Post Operative Cognitive Dysfunction. Assessing

cognitive impairment through tools like Quality of recovery questionnaire QoR15,

Confusion assessment Method CAM score, Mini mental scale examination MMSE,

provide a better understanding of the post operative recovery profile.

In Prolonged laparoscopic surgeries, the response of the patient during intraoperative

positioning, usage of Carbon dioxide gas, and haemodynamic alterations, could all be

exaggerated when considered for an elderly patient.

Thus, it is crucial to have balanced and optimal anaesthesia management in elderly

patients to avoid complications in post operative care. BIS monitoring addresses these

challenges by helping anaesthesiologists maintain an optimal depth of anaesthesia,

minimising drug overuse while ensuring patient safety.

Hence, a randomised, prospective study is being proposed in MGH, to evaluate the

impact of using BIS monitoring guided anaesthesia in elderly patients undergoing

prolonged laparoscopic surgeries in comparison to empirically guided anaesthesia care

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
55.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Scheduled for elective laparoscopic surgery under general anesthesia ASA physical status I to III Expected anesthesia duration more than 3 hours.

排除标准

  • History of severe psychiatric/neurological illness Drug allergies Drug or alcohol abuse Major organ dysfunction Pre-existing sleep disorders Poor GCS Inability to perform Assessment scores CAM and MMSE Pregnant and lactating female.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Ananya Chaturvedi

Mahatma Gandhi Medical College And Hospital

研究点 (1)

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