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临床试验/CTRI/2025/04/085115
CTRI/2025/04/085115尚未招募不适用

Effect of Intraoperative Binaural beat on anaesthetic drug dose and depth of anaesthesia in laproscopic cholecystectomy cases under general anaesthesia- prospective randomized control study

Dr Sneha Kumari Pandey1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年5月17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
70
试验地点
1
主要终点
1 Depth of anaesthesia achieved with or without intraoperative binaural beat

研究概览

简要总结

The patients undergoing lap cholecystectomy will be divided into two groups, by computer generated randomization.patients will be observed under general anaesthesia with propofol infusion and binaural beat application through headphone for anaesthetic dose requirement and depth of anaesthesia. Depth will be monitored by BIS index.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists Physical status I and II weight less than 60 killograms Patients with informed and written consent.

排除标准

  • Patients with history of epilepsy Patients with deafness Patients with allergy to midazolam and propofol Patients with psychotic and cognitive disorder.

结局指标

主要结局

1 Depth of anaesthesia achieved with or without intraoperative binaural beat

时间窗: 5 10 15 30 45 60 minutes after application of binaural beat and start of propofol infusion

2 Requirement of propofol to achieve same depth of anaesthesia

时间窗: 5 10 15 30 45 60 minutes after application of binaural beat and start of propofol infusion

次要结局

  • Evaluation of vital parameters like heart rate, Non invasive blood pressure, SPO2, End tidal CO2(5,10,16,30,45,60 minutes till end of surgery)

研究者

发起方
Dr Sneha Kumari Pandey
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr sneha kumari pandey

Rajendra Institute Of medical sciences

研究点 (1)

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