Clinical evaluation of dexmedetomidine as an adjuvant to bupivacaine in subarachnoid block for lower abdominal surgery:A randomized double blind controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Onset, Peak And Duration Of Sensory And Motor Block.
研究概览
简要总结
Dexmedetomidine is an alpha-2 adrenergic receptor agonist recently introduced in indian market.
It has been used for premedication, as an adjuvant to general anaesthesia and for sedation in the intensive care unit. The aim of the present study is to evaluate the efficacy and safety of dexmedetomedine as an adjuvant to bupivacaine in subarachanoid block.
Study will be carried out in 100 ASA physical status 1 and 2 aged 30 to 60 years going to undergo elective lower abdominal surgery. Patient will be randomly allocated in 2 groups each of 50 by distributing sealed envelopes.1st group will be given bupivacaine and 2nd group will be given bupivacaine and dexmedetomidine in subarachnoid space. Patients will be assessed for onset, peak, duration and regression of sensory and motor block produced by boath groups. Sedation, analgesia, haemodynemic variables and complications will be recorded intraoperatively. Patients will be observed for 24 hours in post operative period. Data will be expressed as mean and standard deviation or numbers and percentages as applicable. Comparison between two groups will be done using unpaired t test for quantitative data and chi sqaure test for qualitative data. p value <0.05 is considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Age: 30 to 60 years.
- •3.Patients posted for lower abdominal surgery; i.
- •4.Informed written consent for participation in study.
- •5.BMI 25 kg/m2.
排除标准
- •Uncontrolled or labile hypertension.
- •Contraindication to spinal anaesthesia.
- •Allergy to local anaesthetic or study drug.
- •Body mass index >25 kg/m2.
- •Patients taking any analgesics sedative or antihypertensive drugs.
- •Neurological disorders.
- •Psychiatric disorders.
- •Unco- operative patients.
结局指标
主要结局
Onset, Peak And Duration Of Sensory And Motor Block.
时间窗: 0 min, 1 min, 2min, 3min, 5min, 10min, 15min,20min, 30min, 45min, 60min, 75min, 90min, 105min, 120min,135min, 150min,165min, 180min, 210min, 240min, 270min, 300min, 330min, 360min(6 hours), 8 hours, 10hours, 12hours, 14hours, 16hours, 20hours and 24hours.
次要结局
- Post Operative Analgesia,Sedation And Complication If Any Withon 24 Hours Of Subarachnoid Block(0 min, 1 min, 2min, 3min, 5min, 10min, 15min,20min, 30min, 45min, 60min, 75min, 90min, 105min, 120min,135min, 150min,165min, 180min, 210min, 240min, 270min, 300min, 330min, 360min(6 hours), 8 hours, 10hours, 12hours, 14hours, 16hours, 20hours and 24hours.)