CTRI/2014/11/005220招募中4 期
Randomised double blind comparative study of three different doses of iv dexmedetomidine for prevention of post spinal anesthesia shivering in patients undergoing transurethral resection of prostate
Indira Gandhi Institute of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年7月11日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To estimate minimum effective dose of intravenous dexmedetomidine to prevent shivering in patients undergoing TURP under spinal anesthesia , to observe other effects like sedation, hypotension, bradycardia
研究概览
简要总结
150 patients, aged 50-75 yrs,undergoing TURP under spinal anesthesia,will be divided into three groups and will receive iv dexmedetomidine as 0.5, 0.75,1.0 microgram/Kg bwt just after spinal anesthesia to prevent shivering. Hemodynamic parameters (pulse rate,BP,MAP,SpO2,resp.rate)as well as sedation and shivering,if present, will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age gr-50 to 75 yrs Patients undergoing TURP ASA 1 and 2 Those willing to give written consent.
排除标准
- •Allergic to drugs,Contraindications to spinal anesthesia,treatment with alpha blockers,opioids or sedatives use,endocrinal,Cardiopulmonary,hepatic,renal,neurological,psychological disorders,blood transfusion during surgery,initial body temperature >38 or <36C,severe bradycardia or hypotension.
结局指标
主要结局
To estimate minimum effective dose of intravenous dexmedetomidine to prevent shivering in patients undergoing TURP under spinal anesthesia , to observe other effects like sedation, hypotension, bradycardia
时间窗: 2 years
次要结局
- To observe effects like sedation, hypotension, bradycardia(2years)
研究者
研究点 (1)
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