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临床试验/CTRI/2022/09/045923
CTRI/2022/09/045923尚未招募不适用

A Comparison between Intrathecal Nalbuphine and Intrathecal Dexmedetomidine as adjuvant to 0.5% hyperbaric bupivacaine for orthopedic surgery of lower limbs under Sub Arachnoid Block

JNUIMSRC1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月30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
60
试验地点
1
主要终点
onset of sensory and motor blocks

研究概览

简要总结

60 patients posted for orthopedic surgery of lower limbs under spinal anaesthesia will be studied to compare the effects of intrathecal dexmedetomidine with hyperbaric bupivacaine and intrathecal nalbuphine with hyperbaric bupivacaine.

The study will comprise of 2 groups of 30 patients each of ASA  grade 1 and 2 status.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

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

入选标准

  • ASA 1 and 2.

排除标准

  • Bleeding diathesis local infection severe systemic diseases spinal deformities and surgery not willing to give consent.

结局指标

主要结局

onset of sensory and motor blocks

时间窗: onset of sensory and motor blocks at 2, 4, 6, and 8 minutes | Duration of analgesia at 2, 3, 4, and 5 hours | duration of sensory and motor blocks at 60, 90, 120, 150, and 180 minutes | duration of analgesia

duration of sensory and motor blocks

时间窗: onset of sensory and motor blocks at 2, 4, 6, and 8 minutes | Duration of analgesia at 2, 3, 4, and 5 hours | duration of sensory and motor blocks at 60, 90, 120, 150, and 180 minutes | duration of analgesia

duration of analgesia

时间窗: onset of sensory and motor blocks at 2, 4, 6, and 8 minutes | Duration of analgesia at 2, 3, 4, and 5 hours | duration of sensory and motor blocks at 60, 90, 120, 150, and 180 minutes | duration of analgesia

次要结局

  • any side effects(every 30 minutes)

研究者

发起方
JNUIMSRC
申办方类型
Private medical college

研究点 (1)

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