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临床试验/CTRI/2025/07/091918
CTRI/2025/07/091918尚未招募4 期

A prospective randomized comparative study of recovery time by using bispectral index versus end tidal agent concentrate monitoring in patients undergoing elective breast surgeries in a tertiary cancer care hospital

DR BABY LALMALSAWMI1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月16日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To assess extubation time and recovery time using bispectral index and end tidal anaesthetic agent

研究概览

简要总结

This a randomized comparative study on recovery time from post operative procedure using two monitoring device bispectral index and end tidal anaesthetic agent. this two device have been proven to be effective for this purpose it also assess the anaesthetic depth of the patients as well. Group A will be the bispectral group where the value will be kept between 40-60 and Group B will be the end tidal anaesthetic agent group where the minimum  alveolar concentratiuon (MAC) will be kept at 1. After shifting the patients to operation room, the will be connect to standard american socitey of anaesthsiology monitor like like heart rate, oxygen saturation , bloopd pressure,electrocardiogramand will recorded at baseline, at 5minustes, at 30 minustes, at 60 minutrs, at 120 minutes. For anaesthetic agent desflurane will be used and will be titrated according to the bispectral index value and end tidal agent value (MAC) and will be switch off an the last stitch of skin incision.the time taken for the patient to be extubated and recover from sugery will be recorded in both the group .

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective breast surgery
  • Patients aged more than 18 years
  • American Society of Anaesthesiology (ASA) physical status 1 and 2
  • Provised consent to procedure.

排除标准

  • Patients with history of long term used of anti-convulsants, opiates, benzodiazepines, cocaine, alcohol
  • Patients with pre-existing renal, hepatic, cardiac disease and dementia.

结局指标

主要结局

To assess extubation time and recovery time using bispectral index and end tidal anaesthetic agent

时间窗: 2-3hours

次要结局

  • total consumption of desflurane, hemodynamic stability of the patients and discharge from post-anaesthetic care unit(1-2hours)

研究者

发起方
DR BABY LALMALSAWMI
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR BABY LALMALSAWMI

KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY

研究点 (1)

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