跳至主要内容
临床试验/CTRI/2018/02/012149
CTRI/2018/02/012149招募中Phase 3 4

Comparative study between intrathecal magnesium sulphate and intrathecal fentanyl as an adjuvant to Bupivacaine in spinal anesthesia for patients undergoing lower limb orthopedic surgery

DEPARTMENT OF ANAESTHESIOLOGY IGIMS PATNA BIHAR1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6月3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
100
试验地点
1
主要终点
Post-operative analgesic effect

研究概览

简要总结

Comperative study between intrathecal magnesium sulphate and intrathecal fentanyl as an adjuvant to Bupivacaine in spinal anesthesia for patients undergoing lower limb orthopaedic surgery

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA grade 1 and 2 patients 2.Age group 18-60 years of either sex 3.Patients giving valid informed consent 4.Height 150-180cm and those undering lower limb orthopedic surgery.

排除标准

  • 未提供

结局指标

主要结局

Post-operative analgesic effect

时间窗: Post-operative analgesic effect

次要结局

  • Nausea,Vomitting,Hypotension,Bradycardia,Respiratory depression,Pruritus,Urinary retention,maximum sedation score(1 min,5 min,10 min,15 min,20 min,25 min, 30 min,35 min,40 min,45 min, 50 min, 55 min, 60 min)

研究者

发起方
DEPARTMENT OF ANAESTHESIOLOGY IGIMS PATNA BIHAR
申办方类型
Government medical college

研究点 (1)

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