Comparison between intravenous Dexmedetomidine and Magnesium Sulphate on intraoperative hemodynamics and postoperative pain in lumbar spine surgeries: A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intraoperative hemodynamics Systolic blood pressure(SBP), Diastolic blood pressure (DBP) , Mean arterial blood pressure (MAP) and heart rate (HR)
研究概览
简要总结
This study is a randomised, double blind, parallel Group, single centre trial comparing the efficacy between intravenous Dexmedetomidine given as Bolus dose of Magnesium Sulpfate 30mg/kg in 100ml Normal Saline over 15 min followed by maintenance of 8mg/kg/hr until end of surgery and intravenous Magnesium Sulphate given as Bolus dose of Dexmedetomidine 1mcg/kg in 100ml Normal Saline over 15 min followed by maintenance of 0.3mcg/kg/hr until end of surgery. The duration of the trial will be a period of two years. The primary outcome measured are intraoperative hemodynamics Systolic blood pressure(SBP), Diastolic blood pressure (DBP) , Mean arterial blood pressure (MAP) and heart rate (HR). The secondary outcome is postoperative pain scores measured with numerical rating scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18-59 years, undergoing elective lumbar spine surgeries Either sex American physical status (ASA) I and II.
排除标准
- •Known history of hypersensitivity to drugs used Pregnant or lactating woman Previous spine surgeries Preexisting neuromuscular diseases or myopathy Coagulation disorders Patient on Calcium channel blockers and Beta blockers.
结局指标
主要结局
Intraoperative hemodynamics Systolic blood pressure(SBP), Diastolic blood pressure (DBP) , Mean arterial blood pressure (MAP) and heart rate (HR)
时间窗: Every 5min for first half hour and then every 15min thereafter until end of surgery.
次要结局
- postoperative pain by measuring numeric rating scale(Parameters are seen in recovery room (0 min, 30min, 1hr, 2hrs) and in ward at 4hrs, 6hrs, 8hrs, 10hrs, 12hrs.)