Efficacy of Oral Gabapentin vs Oral Tramadol Pretreatment in prevention of post spinal shivering- A Randomised controlled trail.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- To compare the onset of shivering after spinal anaesthesia between the groups
研究概览
简要总结
Shivering is a common complication after subarachnoid block with a reported incidence of 40 to 50%. Shivering increases the oxygen demand by 200-500% and can cause various metabolic changes . Shivering can also lead to compromised myocardial and pulmonary functions. Tramadol is the most commonly used drug with less side effects. Newer alternate drugs like Gabapentin are currently being investigated for its role in prevention of post -spinal shivering . The present study is planned to compare premedication with oral gabapentin and oral tramadol for prophylaxis of post-spinal shivering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age more than 18 years 2.American Society of Anaesthesiologists (ASA) I AND II 3.Elective surgery under spinal anesthesia.
排除标准
- •1.History of allergy to opioids and gabapentin 2.Patient already on tramadol and gabapentin 3.History of opioids abuse 4.Febrile patient 5.Patient with psychiatric illness or communication difficulty.
结局指标
主要结局
To compare the onset of shivering after spinal anaesthesia between the groups
时间窗: for 2-4 hours after spinal anaesthesia
次要结局
- 1.To observe the severity of shivering(2.To observe the therapeutic dose of fentanyl to control shivering)
研究者
Dr Lovepreet Singh
Kalinga Institute of Medical Sciences (KIMS)