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临床试验/CTRI/2025/07/090863
CTRI/2025/07/090863尚未招募不适用

To compare the efficacy of intravenous Tramadol and Ketamine for prevention of shivering in patients undergoing transurethral resection of prostate under spinal anaesthesia

PGIMS ROHTAK Pt BD Sharma University Of Health Scienca1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Both Tramadol and Ketamine have been succesfully used for their prophylactic role in shivering after neuraxial anaesthesia

研究概览

简要总结

After reviewing the literature, we found that both Tramadol and Ketamine have been successfully used for their prophylactic role in shivering after neuraxial anaesthesia. Also, various studies have shown contradictory results on effectiveness of prophylactic low doses of tramadol and ketamine. There is also a gap in showing better prophylactic agents concerning the effectiveness of prevention of post spinal anaesthesia shivering incidence, severity and occurrence of adverse effects.

After thorough search of literature, we could not find any research work done comparing the efficacy of intravenous tramadol and intravenous ketamine in prevention of shivering in patients undergoing TURP under spinal anaesthesia. Hence we intend to conduct this study to compare the efficacy of intravenous Tramadol and Intravenous ketamine for prevention shivering in patients undergoing transuretheral resection of prostate under spinal anaesthesia.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
Male

入选标准

  • Patients belonging to the American Society of Anaesthesiologists- Physical Status I and II and aged between 40 and 75years undergoing elective TURP under spinal anaesthesia.

排除标准

  • patients refusing to give consent, hypersensitivity to study drugs, who develop shivering before administeration to study drugs, patients on vasodilators/ vasocontrictors.

结局指标

主要结局

Both Tramadol and Ketamine have been succesfully used for their prophylactic role in shivering after neuraxial anaesthesia

时间窗: we will assess the shivering if any, every 5 minutes intraoperatively and every 10 minutes post operatively for 1 hour

次要结局

  • To evaluate adverse effects associated with use of study drugs , if any like nausea/vomiting, sedation, hypotension also bradycardia(Adverse effects will be assessed intra operatively as well as 1 hour after the surgery)

研究者

发起方
PGIMS ROHTAK Pt BD Sharma University Of Health Scienca
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anju Rani

Pt, BD Sharma PGIMS Rohtak

研究点 (1)

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