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临床试验/CTRI/2021/09/036556
CTRI/2021/09/036556尚未招募不适用

Comparison of block characteristics of intrathecal CLONIDINE and FENTANYL as adjuncts to hyperbaric BUPIVACAINE in lower segment caesarean section

nazareth hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年9月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
试验地点
1
主要终点
To evaluate block characteristics of Intrathecal CLONIDINE versus FENTANYL as adjuncts to BUPIVACAINE in caesarean section

研究概览

简要总结

This is a randomized comparative study designed with a primary objective to determine whether  doses of 0.5mcg/kg FENTANYL and 0.5mcg/kg CLONIDINE are equally effective when given as adjuncts to hyperbaric BUPIVACAINE 0.06mg/cm of height for spinal anaesthesia in LSCS. The study will compare the onset and duration of sensory and motor block, intraoperative hemodynamic parameters and  post operative analgesic requirement. Secondary objective of the study will be to compare the levels of sedation, and associated side effects with the 2 drugs.

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
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patients with singleton pregnancy, belonging to ASA grade I and II
  • Patients posted for elective and emergency LSCS.

排除标准

  • 1.Patients with major neurological, cardiovascular, respiratory, renal, coagulation disorders 2.Patients with known hypersensitivity to local anaesthetics or study drugs.
  • 3.Patients with local infection/spine deformity 4.Patients who refuse to give consent.
  • 5.Patients whose height an weight cannot be measured before the surgery.

结局指标

主要结局

To evaluate block characteristics of Intrathecal CLONIDINE versus FENTANYL as adjuncts to BUPIVACAINE in caesarean section

时间窗: 1 year

次要结局

  • to compare the levels of sedation and associated side effects with the 2 test drugs(1 year)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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