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临床试验/CTRI/2023/04/051460
CTRI/2023/04/051460尚未招募不适用

A RANDOMIZED CONTROLLED STUDY TO COMPARE INTRATHECAL FENTANYL, DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANTS TO HYPERBARIC BUPIVACAINE FOR LOWER LIMB SURGERY IN ADULT PATIENTS

Jawaharlal Nehru Medical College AMUAligarh1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年12月4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
Duration of sensory and motor block

研究概览

简要总结

Spinal, epidural or combined spinal-epiduralanaesthesia are the most popular and reliable techniques for lower limbsurgery. Prolongation of intraoperative and postoperative intrathecalanaesthesia and analgesia has been achieved by addition of various adjuvantssuch as Fentanyl, epinephrine and alpha-2 agonists like clonidine anddexmedetomidine. Various clinical trials have found thatadministration of dexmedetomidine, fentanyl and clonidine  with local anaesthetics  prolonged the duration of sensory and motorblockade.

In this study we plan to compare theIntrathecal fentanyl, clonidine and dexmedetomidine as adjuvants tohyperbaric bupivacaine on onset and duration of block , time to two segmentsregressions of block and duration of spinal anaesthesia for elective lower limbsurgery in adult patients.

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 Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • A.S.A I & II Patients Patients planned for elective lower limb surgery under Sub-Arachnoid Block.

排除标准

  • Patients with contraindications to regional anaesthesia 2)Patients with disease like diabetes ,peripheral neuropathy.
  • Patients with history of coexisting diseases like ischaemic heart diseases, hypertension, impaired renal functions, rheumatoid arthritis and severe liver diseases .
  • Patients with known allergy to local anaesthetic 5) pregnant patients, chronic alcoholics, AV Blocks, incomplete heart blocks , intake of alpha-blockers.

结局指标

主要结局

Duration of sensory and motor block

时间窗: The duration of sensory block was defined as the time of regression of two segments in the maximum block height, evaluated by pinprick. | Duration of motor block was defined as time from which patient acheive modified bromage 3 to modified bromage 0.

次要结局

  • 1.Onset of sensory and motor block(2.Time to two segments regressions of block)

研究者

发起方
Jawaharlal Nehru Medical College AMUAligarh
申办方类型
Government medical college

研究点 (1)

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