COMPARISON OF DEXMEDITOMEDINE 10 MICROGRAM AS ADJUVANT FOR INFRAUMBILICAL SURGERY IN PATIENTS RECIEVING ROPIVACAINE 0.75% HEAVY SPINAL ANAESTHESIA: A RANDOMIZED OPEN TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Additives like dexmedetomidine improves quality of sub arachnoid block in terms of Speed of onset of action, Level of Blockade Achieved and Duration of blockade
研究概览
简要总结
This study investigates the effect of adding dexmedetomidine to ropivacaine for spinal anesthesia in lower abdominal surgeries. The research team will compare two groups - one receiving standard ropivacaine and another receiving ropivacaine plus 10 mcg dexmedetomidine. The goal is to determine if the addition improves anesthesia quality by measuring onset time, block duration, and pain relief after surgery.
The trial will include 60 patients undergoing procedures like hernia repairs, randomly assigned to either treatment group. Researchers will monitor sensory and motor block levels, vital signs, and postoperative pain scores. Patients will be followed for 24 hours after surgery to assess pain levels and need for additional pain medication. The study excludes high-risk patients and those with certain medical conditions.
Results will be analyzed statistically to compare outcomes between the two groups. The study expects dexmedetomidine to provide faster pain relief, longer-lasting anesthesia, and better postoperative pain control. Findings could support using this drug combination to improve patient comfort during and after lower abdominal surgeries. The research follows ethical guidelines and will be conducted over 12 months at TNMC and BYL Nair Hospital in Mumbai.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of anaesthesiologists (ASA) Grade I and II.
- •Age between 18-75 years.
- •Patient of either sex.
- •Undergoing lower limb and lower abdominal surgeries (hernias, urological surgeries, lower segment caesarean section etc.).
排除标准
- •Upper abdominal surgeries(incision extend above umbilicus) and cesarean sections.
- •Pt on LMWH and heparin therapy .
- •Pre-existing neurological conditions or surgeries which are waxing and waning in nature(eg: multiple sclerosis,poliomyelitis).
结局指标
主要结局
Additives like dexmedetomidine improves quality of sub arachnoid block in terms of Speed of onset of action, Level of Blockade Achieved and Duration of blockade
时间窗: Both Sensory and Motor blockade will be assessed at 0,3,5,10,20,30,60,90,120,150,180 minutes respectively to determine Time at which T10 level achieved, Highest level achieved and Two segment regression time
次要结局
- Additives like dexmedetomidine into subarachnoid block gives better post operative analgesia(Pain scores will be assessed at immediately Post operative ,Before shifting Out of post operative care unit after two hours & twenty four hours later to look of need of rescue Analgesia)