Efficacy of intravenous tramadol & butorphanol in the treatment of post spinal anesthesia shivering. A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Grade of shivering.
研究概览
简要总结
This primary purpose of the study is to compare the efficacy of intravenous tramadol(0.5mg/kg) and butorphanol(0.02mg/kg) in the treatment of post spinal anaesthesia shivering. A double blinded randomised control trial. We Hypothesise that butorphanol has early onset of control of shivering compared to tramadol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to American society of anaesthesiologist physical status I & II.
- •Age between 18 to 60 years.
- •patient who develop shivering after spinal anaesthesia.
排除标准
- •Patients with hypo or hyperthyroidism 2) Patients with neuromuscular disease 3) Morbid obesity(body mass indexof≥40kg/m2) 4) Fever(axillary temperature>37°C)and 5) Compromised cardio respiratory functions 6) Patients on long term phenothiazines & MAO inhibitors 7) Patients with hepatic & renal insufficiency 8) Allergy to any of the study drugs.
结局指标
主要结局
Grade of shivering.
时间窗: 1)Parameters will be seen at intervals of 1 minute for the first 5 minutes and thereafter 10,15,20,25,30,40,60 minutes till cessation of shivering. | 2)Tympanic membrane temperature will be noted at shivering, and regular intervals of 15,30,45 minutes following shivering. | 3)Control of shivering and grading of shivering will be noted for 20 mins
Complete/incomplete Control of shivering.
时间窗: 1)Parameters will be seen at intervals of 1 minute for the first 5 minutes and thereafter 10,15,20,25,30,40,60 minutes till cessation of shivering. | 2)Tympanic membrane temperature will be noted at shivering, and regular intervals of 15,30,45 minutes following shivering. | 3)Control of shivering and grading of shivering will be noted for 20 mins
Time taken for control of shivering
时间窗: 1)Parameters will be seen at intervals of 1 minute for the first 5 minutes and thereafter 10,15,20,25,30,40,60 minutes till cessation of shivering. | 2)Tympanic membrane temperature will be noted at shivering, and regular intervals of 15,30,45 minutes following shivering. | 3)Control of shivering and grading of shivering will be noted for 20 mins
Recurrence of shivering
时间窗: 1)Parameters will be seen at intervals of 1 minute for the first 5 minutes and thereafter 10,15,20,25,30,40,60 minutes till cessation of shivering. | 2)Tympanic membrane temperature will be noted at shivering, and regular intervals of 15,30,45 minutes following shivering. | 3)Control of shivering and grading of shivering will be noted for 20 mins
Parameters like heart rate, Blood pressure, oxygen saturation and temperature
时间窗: 1)Parameters will be seen at intervals of 1 minute for the first 5 minutes and thereafter 10,15,20,25,30,40,60 minutes till cessation of shivering. | 2)Tympanic membrane temperature will be noted at shivering, and regular intervals of 15,30,45 minutes following shivering. | 3)Control of shivering and grading of shivering will be noted for 20 mins
次要结局
- Complete or incomplete Control of shivering.(Time taken for control of shivering)