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临床试验/CTRI/2025/12/098577
CTRI/2025/12/098577尚未招募不适用

Comparison of patient state index and bispectral index for sevoflurane consumption and end tidal sevoflurane consumption in patients undergoing laparoscopic surgical and gynaecological procedures

RajaRajeswari Medical College & Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月31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
40
试验地点
1
主要终点
To determine the volume of sevoflurane consumed (in ml) in patients, while monitoring depth of anaesthesia using Bispectral Index versus Patient State Index

研究概览

简要总结

Accurate monitoring of anaesthetic depth is essential for optimizing drug delivery, ensuring patient

safety, preventing awareness during anaesthesia and enhancing recovery outcomes and reducing cost during surgical

procedures. In laparoscopic surgical and gynaecological procedures , where optimal anaesthetic dose and rapid

emergence are desirable, the use of brain-function monitors can guide more precise titration of

volatile anaesthetic agents such as sevoflurane.This achieves more significance in ASA 3 and 4 patients where

optimal anesthetic dose will reduce adverse effects.

Two widely used parameters - the Bispectral Index (BIS) and the **Patient State Index (PSI)-**offer real-time

assessment of a patient’s level of consciousness based on processed EEG data. While both aim to

prevent intraoperative awareness and reduce anaesthetic consumption, they rely on different proprietary algorithms

and EEG interpretations. BIS analyzes EEG bispectral and power spectral data, while PSI incorporates bilateral EEG

coherence and anterior-posterior phase relationships.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • ASA 1-2 Scheduled for Laparoscopic gynaecological/surgical procedures.

排除标准

  • Known neurological disorders combined regional- general anaesthesia pregnant or lactating women Patient refusal.

结局指标

主要结局

To determine the volume of sevoflurane consumed (in ml) in patients, while monitoring depth of anaesthesia using Bispectral Index versus Patient State Index

时间窗: Baseline- Time of intubation,5mins,10mins,15mins,20mins,25mins,30mins,35 mins,40mins,45 mins,50mins,55mins,60mins | Post one hour of intubation -every 15mins till the end of surgery

次要结局

  • -To assess the end-tidal sevoflurane concentration (ETSevo) during surgery in both groups(-To compare recovery profiles including time to extubation & response to verbal commands between the two groups.)

研究者

发起方
RajaRajeswari Medical College & Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rangalakshmi S

RajaRajeswari Medical College and Hospital 202 Kambipura Mysore Road Bangalore

研究点 (1)

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