Efficacy of tramadol versus tapentadol for prophylaxis of post spinal shivering in patients undergoing lower limb surgeries
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Shivering characterstic and score
研究概览
简要总结
• Before administration of the oral premedication (study drug), each patients baseline heart rate, mean systemic arterial pressure, pulse oximetry, forehead temperature, tympanic membrane temperature and sedation score will be measured
• One hour prior to surgery patients will receive following premedication drugs as per group randomisation with sips of water
GROUP I : Tab. Tramadol 100 mg
GROUP II: Tab. Tapentadol 50 mg
GROUP III : Placebo
• All the anaesthetic and surgical techniques were standardized. The operation theatres in which the operations will be performed are maintained at constant humidity (65%) and an ambient temperature of 20-22 degree Celsius. Thereafter case would be induced with 25 G spinal needle using ropivacaine heavy 0.75% 3 ml
Primary objective would be to study incidence onset and grade of shivering
Secondary outcome would be sedation,pain and post op nausea vomiting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •ASA 1 and 2 Consent for spinal anaesthesia surgery duration less than 2 hours.
排除标准
- •ASA 2 and 3 Refusal or contraindication for spinal Significant cardiac disease, renal failure, asthama Patient with chronic analgesic use Patient with endocrine abnormalities like thyroid disease, diabetes and mental disorder Current or recent ( within 14 days ) use of MAO inhibitors.
结局指标
主要结局
Shivering characterstic and score
时间窗: till 6 hours after completion of surgery
次要结局
- Ramsay sedation score(6 hours post administration of drug)
研究者
Devangi Moudgil
Himalayan Institute of Medical Sciences