临床试验/CTRI/2025/01/079607

CTRI/2025/01/079607尚未招募Phase 3 4

Comparison of the effect of propofol versus ketofol on emergence from anesthesia in patients undergoing elective supratentorial craniotomy, a prospective randomized double-blind study

All India Institute of Medical Sciences1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2025年2月7日最近更新: 2025年1月22日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方: All India Institute of Medical Sciences
入组人数: 70
试验地点: 1
主要终点: Time for emergence

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Our study proposes a prospective RCT to compare the effects of ketofol versus propofol based anesthesia on emergence from anesthesia in patients undergoing craniotomy for supratentorial tumors.

Additionally, we will also be evaluating the intraoperative hemodynamics and brain bulge in these patients and the time taken for extubation and recovery from anesthesia.

This research will provide valuable information related to an optimal maintenance agent for anesthesia in patients undergoing neurosurgery.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

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 grade I & II patients, patients with supratentorial tumor size less than 5 cm, posted for elective craniotomy for tumor excision.

排除标准

•Refusal of consent, patients who are expected to need postoperative elective ventilation having massive cerebral edema, midline shift, vascular or high-grade tumor, expected duration of anesthesia greater than eight hours, patients with preoperative GCS less than fifteen, altered sensorium or having aphasia, patients with BMI more than thirty five kg per meter square, pregnant females, patients having psychiatric illness or drug abuse, patients having aphasia, patients requiring post-operative ventilation, patients having history of allergic reactions to study drug, history of previous craniotomy.

结局指标

主要结局

Time for emergence

时间窗: One point assessment at the end of surgery

次要结局

Heart rate & mean arterial pressure, Intra-operative brain bulge, Time for extubation, Time for recovery, SOMCT in the early postoperative period, Post-operative nausea & vomiting during the early recovery period, Complications of study drugs

研究者

发起方

All India Institute of Medical Sciences

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Dr. Bhavna

AIIMS, New Delhi

研究点 (1)

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