Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Incidence of shivering
研究概览
简要总结
The objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 40 years
- •American Society of Anesthesiologist physical status I and II
- •Pregnant female for lower segment caeserian section
排除标准
- •Patients with Hypertension
- •Patients with hypo- or hyperthyroidism
- •Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia
- •An initial body temperature 38.00C or, 36.0oC assessed by thermometer
研究组 & 干预措施
Tramadol with Ketamine
Tramadol 0.25mg/Kg with Ketamine 0.25 mg/Kg
干预措施: Tramadol with Ketamine (Drug)
Tramadol
Tramadol 0.5mg/kg
干预措施: Tramadol (Drug)
结局指标
主要结局
Incidence of shivering
时间窗: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Muscular activity in one or more than one muscle group or involving the whole body will be labelled as shivering
Severity of Shivering
时间窗: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Shivering will be graded as per the following criteria: 0= no shivering. 1. piloerection or peripheral vasoconstriction but no visible shivering. 2. muscular activity (visible muscular twitching) in only one muscle group; 3. muscular (visible muscular twitching) activity in more than one muscle group but not generalized. 4. shivering involving the whole body
次要结局
- Time to shivering(15 mins from the administration of the prophylactic drug)
- Complications(Patients will be monitored from 15-45 mins from the administration of the prophylactic drug)
研究者
Dr Muhammad Arif
Principal Investigator
Ziauddin University