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临床试验/CTRI/2026/03/106731
CTRI/2026/03/106731尚未招募Phase 3 4

Comparative study of effect of Dexmedetomidine and Propofol on Intraoperative Awareness under general anaesthesia in Neurosurgical Patients.

Datta Meghe Institute of Higher Education and Research,1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
Phase 3 4
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

The study titled Comparative Study of Effect of Dexmedetomidine and Propofol on Intraoperative Awareness Under General Anaesthesia in Neurosurgical Patientsaims to evaluate the effectiveness of dexmedetomidine compared with propofol in preventing intraoperative awareness during neurosurgery. Intraoperative awareness is a significant complication of general anaesthesia that may result in psychological distress such as anxiety, depression, or post-traumatic stress disorder. This prospective randomized controlled trial will be conducted in the Department of Anaesthesia at Acharya Vinoba Bhave Rural Hospital, Wardha, involving 60 adult patients aged 18 to 60 years undergoing elective neurosurgery. Participants will be randomly divided into two groups: one receiving propofol and the other dexmedetomidine as the maintenance anaesthetic agent. Depth of anaesthesia will be monitored using entropy monitoring, and postoperative awareness will be assessed using the modified Brice questionnaire. Hemodynamic parameters, recovery time, and adverse effects will also be compared. The study seeks to determine whether dexmedetomidine provides better prevention of intraoperative awareness and improved hemodynamic stability compared to propofol.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Patient willing to give informed consent (ANNEXURE 1)
  • ASA grade I, II and III.(ANNEXURE 3)
  • Patients scheduled for elective neurosurgery under general anaesthesia
  • Patients aged between 18 and 60 years.

排除标准

  • Patient not willing to give informed consent
  • Patients known to have an allergy or hypersensitivity to dexmedetomidine and propofol.
  • Surgeries exceeding 3 hours
  • Patients with a heart rate of less than 50/min.

研究者

发起方
Datta Meghe Institute of Higher Education and Research,
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Amrita M

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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