CTRI/2023/10/058395已完成4 期
Evaluation of two different doses of Gabapentin given as preemptive analgesia for Lumbar Laminectomy- A Randomized Double-Blind Study
Lourdes hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年10月16日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1) Postoperative pain measured using Visual Analogue Scale
研究概览
简要总结
The present study is a randomized, double-blind, parallel group study to identify the optimal preemptive analgesic dose of gabapentin. I hypothesize that 300 mg of gabapentin is as effective efficacious as 600 mg of gabapentin for preemptive analgesia following lumbar laminectomy under general anesthesia. The primary outcomes to be measured are VAS score and consumption of rescue analgesic for the first 24 hours postoperatively. The secondary outcomes to be measured are Modified RSS and postoperative nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 and 2 patients undergoing elective lumbar laminectomy under general anesthesia.
排除标准
- •ASA 3 and 4 2) Pregnant and lactating patients 3) Patients on maintenance dose of gabapentin for any indication 4) Emergency surgery 5) Drug allergy to gabapentin or any common drugs that are used during general anesthesia 6) Prolonged surgery more than 4 hours.
结局指标
主要结局
1) Postoperative pain measured using Visual Analogue Scale
时间窗: 0,1,2,4,6,8,12,24 hours postoperatively
2) Consumption of rescue analgesic
时间窗: 0,1,2,4,6,8,12,24 hours postoperatively
次要结局
- 1) Modified Ramsay Sedation Score(2) Postoperative nausea and vomiting)
研究者
研究点 (1)
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