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临床试验/CTRI/2022/03/041442
CTRI/2022/03/041442已完成不适用

Subarachnoid block characteristics following coadministration of Fentanyl premixed with hyperbaric Bupivacaine versus antecedent or succedent to hyperbaric Bupivacaine. A randomised controlled study.

Mahatma Gandhi Medical College1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年3月31日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1
主要终点
To study the Onset and Duration of Sensory and Motor block in minutes.

研究概览

简要总结

Subarachnoid block is the most commonly used anesthesia technique for lower limbsurgeries and hyperbaric Bupivacaine is the most commonly used local anesthetics for it. Several adjuvants or additives including various opioids, alpha agonists, neostigmine, ketamine, dexamethasone have been used mixing with the bupivacaine to enhance the quality of subarachnoid block.

Though the Fentanyl has been used extensively premixed with hyperbaric bupivacaine for spinal anesthesia, there is paucity of literature on clinical effects and understanding of mechanism of influence of fentanyl on subarachnoid block produced by hyperbaric bupivacaine when administered separately by another syringe, either before or after bupivacaine.

We propose that cerebrospinal fluid dynamics and pharmacokinetics may be affected differently when fentanyl is co-administered in subarachnoid space premixed with bupivacaine compared to when administered separately before or after hyperbaric Bupivacaine. That is the rationale of proposal for conducting this clinical study where in we wish to evaluate the difference in onset and duration of sensory and motor block and the incidence of hypotension after administering hyperbaric Bupivacaine and Fentanyl either in a single syringe or in different syringes prior to hyperbaric Bupivacaine and vice versa.

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, 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.Patients scheduled for elective lower limb surgeries under subarachnoid block.
  • 2.Patients weighing 50 to 70 kgs.
  • 3.Patient under ASA CLASS I/ II /III.
  • 4.Patient’s with written and informed consent.

排除标准

  • 1.Patient belonging to ASA CLASS IV & V.
  • 2.Patients allergic to the study drugs.

结局指标

主要结局

To study the Onset and Duration of Sensory and Motor block in minutes.

时间窗: Intraoperative

To study the variation in Systolic and Diastolic BP, Mean Arterial Pressure, Heart Rate, Respiratory Rate, SPO2.

时间窗: Intraoperative

次要结局

  • 1.To assess the need of rescue postoperative analgesia in next 24 hr.(2.To study the postoperative side effects viz Nausea, vomiting, Itching, Urinary retention, respiratory depression etc.)

研究者

发起方
Mahatma Gandhi Medical College
申办方类型
Private medical college

研究点 (1)

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