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临床试验/CTRI/2025/07/091683
CTRI/2025/07/091683尚未招募不适用

Comparison of the effect of intrathecal Dexmedetomidine versus Buprenorphine as an adjuvant to Bupivacaine in spinal anaesthesia in lower limb orthopedic surgeries

Department Of Anaesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Onset and duration of sensory and motor blockade.

研究概览

简要总结

The supplementation of local anesthetics with adjuvants improve the efficacy of subarachnoid block.

This study was conducted to evaluate and compare the characteristics of subarachnoid block such as sensory and motor onset and duration , along with that the hemodynamic changes and adverse effects of intrathecal dexmedetomidine versus buprenorphine as an adjuvant with hyperbaric bupivacaine.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) grade 1 and 2 patients undergoing lower limb orthopedic surgeries.

排除标准

  • Study drug contraindicated.
  • contraindication of spinal anesthesia.
  • spinal deformity.

结局指标

主要结局

Onset and duration of sensory and motor blockade.

时间窗: 2 minute , 3 minute , 5 minute , 10 minute, 15 minute , 20 minute , 30 minute, 45 minute , 1 hour , 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour, 18 hour and 24 hours after spinal anesthesia.

次要结局

  • Hemodynamic changes such as heart rate, systolic blood pressure, diastolic blood pressure , mean arterial pressure & need of post op analgesia.(Time since induction of anesthesia, intraoperatively at interval of 5 minutes for first 20 minutes followed by every 10 minutes for next 20 min followed by 30 minutes then at 2,4,6,9,12,24 hours.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kachekar Aarti Suresh

Vilasrao Deshmukh Government Medical College, Latur

研究点 (1)

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