CTRI/2022/09/046008尚未招募Phase 3 4
A prospective randomised comparative double blinded study to evaluate the effect of dexmedetomidine versus lidocaine infusion in spine surgery on post operative analgesia at SMS Medical College and attached group of hospitals, Jaipur during 2021-2023.
Department of Anaesthesiology1 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
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean duration of requirement of first rescue analgesia in post operative period.
研究概览
简要总结
in this study we will compare the effect of intravenous dexmedetomidine versus intravenous lidocaine in patients undergoing spine surgey on postoperative analgesia using ramsay sedation score, haemodynamic parameters.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient undergoing spine surgery with duration within 3 hrs.
- •ASA Grade I&II.
- •Weight 40-80 kg.
- •written and informed consent.
排除标准
- •Patients with a known history of hepatic disese, renal dysfunction, hypertension, atrioventricular block.
- •history of hypersensitivity to study medication Patients having chronic pain or concomittantly taking clonidine, methyldopa, beta blockers, benzodiazapines.
- •Patients having unstable Haemodynamic parameters.
结局指标
主要结局
Mean duration of requirement of first rescue analgesia in post operative period.
时间窗: immediate post op, after 1hr, 4hr,8hr,12hr,till 24 hr.
次要结局
- mean number of doses of total rescue analgesia required.(just after surgery, at 1hr, 4hr,8hr,12hr till 24hr.)
- haemodynamic parameters(Mean HR, Mean SBP, Mean DBP, Mean BP,SPO2(intraoperative(baseline, at begining of infusion, at 5 min,10 min,15 minthen every 15 min till 180 min), and postoperative (immediate,at 1hr, 4hr,8hr,12 hr,24 hr).)
- Median Ramsay sedation score(postoperative period(immediate,1hr,4hr,8hr,12hr,24hr))
- Proportion of cases with any complications and side effects(postoperative period till 24 hr)
研究者
研究点 (1)
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