临床试验/CTRI/2024/05/067687

CTRI/2024/05/067687已完成3 期

Effect Of Sugammadex Vs Neostigmine On Bispectral Index In Elderly Patients Undergoing Urology Surgeries Under Steady State Total Intravenous Propofol Anesthesia: A Randomized Parallel Group Trial

Department of Anaesthesiology and Critical Care AIIMS Bhubaneswar1 个研究点分布在 1 个国家目标入组 46 人开始时间: 2024年5月29日最近更新: 2025年12月10日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 46
试验地点: 1
主要终点: To compare the effect of sugammadex versus neostigmine on change of BIS value at end of surgery (time point t0 - just after skin closure) and at TOF count 4 with TOF ratio more than 0.7 (time point t1 - Primary end point)

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

There are no studies on the effect of neuromuscular blockade reversal on BIS and other processed EEG parameter in elderly patients . We hypothesise that the use of suggamadex as compared to neostigmine would lead to higher BIS and thereby better neurocognitive outcomes in elderly patients.

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: 65.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•American Society of Anaesthesiology Physical Status 1-3 Urology surgery Requiring general anesthesia.

排除标准

•Anticipated post op mechanical ventilation Severe renal impairment (creatinine more than 2mg/dl) History Of Uncontrolled thyroid disorder, MI History of anaphylaxis/severe reaction to any administered drug Consent refusal Limitation to using BIS (History of central brain injury, pacemaker, Parkinsonâ€™s).

结局指标

主要结局

To compare the effect of sugammadex versus neostigmine on change of BIS value at end of surgery (time point t0 - just after skin closure) and at TOF count 4 with TOF ratio more than 0.7 (time point t1 - Primary end point)

时间窗: At time of surgery- | t0 - just after skin closure | t1 - TOF count 4 with TOF ratio more than 0.7

次要结局

Sedation score using Modified Observer Assessment of Alertness & Sedation (MOAAS) scale at timepoint t1.

研究者

发起方

Department of Anaesthesiology and Critical Care AIIMS Bhubaneswar

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Bhavesh Gupta

AIIMS Bhubaneswar

研究点 (1)

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