跳至主要内容
临床试验/CTRI/2017/08/009281
CTRI/2017/08/009281招募中Phase 3 4

Comparison of intrathecal Dexmedetomidine and Buprenorphine as adjuvant to Bupivacaine for lower limb surgeries

Father Muller hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年10月17日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
To check which drug has better outcome as adjuvants to intrathecal Bupivacaine

研究概览

简要总结

Spinal anesthesia is widely used anesthesia.

It is beneficial, cheap.

Many studies are done to increase the efficacy of spinal anestheia.

Buprenorphine and Dexmedetomidine are used as adjuvants for such purpose.

Objective is to compare the efficacy of these two drugs when used as adjuvants to intrathecal Bupivacaine

研究设计

研究类型
Interventional
分配方式
Adaptive randomization, such as minimization
盲法
Double Blind Double Dummy

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients between age 15-65yrs undergoing elective surgery .
  • 2 ASA class I and 2.

排除标准

  • 1 Patients with cardiac disease, heart block, dysarrythmia, beta blockers and alpha antagonist 2 ASA class 3 and
  • 3 Patients not wiling for spinal anaesthesia.
  • 4 Allergy to drugs.
  • 5 History of drug abuse, space occupying lesion, bleeding disorders.

结局指标

主要结局

To check which drug has better outcome as adjuvants to intrathecal Bupivacaine

时间窗: FOR A PERIOD OF 2 YEARS | June 2018

次要结局

  • To monitor its effect on post operative pain relief(For a period of 2 years)

研究者

发起方
Father Muller hospital
申办方类型
Private medical college

研究点 (1)

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