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临床试验/CTRI/2023/10/058666
CTRI/2023/10/058666尚未招募4 期

A Comparative Analysis Of The Effects Of Two Different Infusion Doses Of Dexmedetomidine On Hemodynamic Response To Extubation And The Quality OF Extubation In The Neurosurgical Patients

Rajendra institute of medical sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年10月21日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
To observe the airway response during tracheal extubation

研究概览

简要总结

It is a triple blind RCT, of 3 groups with 30 participants in each group, it is a comparative analysis of the effects of two different infusion doses of dexmedetomidine on hemodynamic response to extubation and the quality of extubation in the neurosurgical patients. D1 group will receive drug at a dose 0.4mcg/kg/hr and D2 will receive drug at a dose rate of 0.6mcg/kg/hr and the group C. Will be the control group will receive Normal saline. 20ml of the solution will be started at the end of surgery for about 20min and the vitals and the quality of extubtion are recorded.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient giving informed and written consent 2.ASA physical class 1 and 2 3.Patient of supratentorial space occupying lesion 4.Glasgow coma scale 15/15.

排除标准

  • 1.Patient refusal, not giving consent for study.
  • 2.Pregnant and lactating women.
  • 3.Patients undergoing elective surgical procedures in prone position including surgery of spine.
  • 4.Patient having known case of allergy to dexmedetomidine.

结局指标

主要结局

To observe the airway response during tracheal extubation

时间窗: 30 minutes after completion of surgery

To observe the hemodynamic changes during tracheal extubation following two infusion doses of dexmedetomidine.

时间窗: 30 minutes after completion of surgery

次要结局

  • 1. Time to emergence & time to tracheal extubation.(2.Early post operative complications such as coughing, laryngospasm,)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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