临床试验/CTRI/2021/09/036980

CTRI/2021/09/036980尚未招募4 期

A comparative study of Nalbuphine and Fentanyl as adjuvant to Bupivacaine in spinal anesthesia in Lower limb orthopedic surgeries.

Mahatma gandhi medical college and hospital1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2021年1月10日最近更新: 2021年9月29日

试验速览

阶段: 4 期
状态: 尚未招募
发起方: Mahatma gandhi medical college and hospital
入组人数: 80
试验地点: 1
主要终点: 1)The characteristic of sensory and motor block

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

we compare effect of fentanyl and nalbuphine as adjuvant to bupivacaine in spinal anaesthesia in lower limb orthopedic surgeries. we compare onset of sensory block , maximum dermatomal block height, onset of complete motor block.

we also compare time of first rescue analgesia , patient satisfaction.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant, Investigator and Outcome Assessor 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

•Patients withASAclass1/2 lower limb surgeries patient giving written and informed consent.

排除标准

•Patient refusal patient with bledding diasthesis,allergic to study drug,neurological disease, spinal deformity, septicemia Patient with local infection at injection site.

结局指标

主要结局

1)The characteristic of sensory and motor block

时间窗: 1)watch for need of post-operative analgesia up to 24 hours | 2)Watch for regression of sensory block up to T10 for 135 min | 2)

2)Comparision of hemodynamic parameter and sedation score

时间窗: 1)watch for need of post-operative analgesia up to 24 hours | 2)Watch for regression of sensory block up to T10 for 135 min | 2)

次要结局

1)Time of first rescue analgesia(2) Patient satisfaction and adverse effect)

研究者

发起方

Mahatma gandhi medical college and hospital

申办方类型

Private medical college

研究点 (1)

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