“A Comparative Study of Dexmedetomidine and Tramadol for prevention of post-spinal anaesthesia shivering .â€
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time of onset of shivering (10 minutes intervals) , after given spinal anesthesia
研究概览
简要总结
- Dexmedetomidine effectively controls shivering and takes almost the same time for cessation of shivering as that of tramadol.
- It provides additional benefit of intraoperative sedation without any incidence of nausea and vomiting.
- The recurrence of shivering will more with tramadol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •Informed written consent for participation in study.
- •Age: 18 to 65 years.
- •Gender: Either gender.
- •Patients with haemodynamic HR >60/min , SBP>100 mmHg , after atleast 15 minutes of administering spinal anaesthesia .
- •Patients scheduled for elective lower abdominal, lower limb, gynaecological procedures as well as caesarean section , orthopedics and plastic surgeries under spinal anaesthesia included in the study .
- •ASA physical status I ,II & III.
排除标准
- •Patients with known hypersensitivity to dexmedetomidine or tramadol .
- •ASA physical status IV and above.
- •History of drug allergy (local anaesthetics).
- •Patients on anticoagulants.
- •History of bleeding disorders.
- •Any major systemic illness like hypertension, heart block etc.
- •Patients with cardio pulmonary , renal and hepatic disease .
结局指标
主要结局
Time of onset of shivering (10 minutes intervals) , after given spinal anesthesia
时间窗: Time of onset of shivering (10minutes intervals) , after given spinal anesthesia | Severity(grading) of shivering | •Time to disappearance of shivering (minute) | •Time of recurrence (min)
Severity of shivering
时间窗: Time of onset of shivering (10minutes intervals) , after given spinal anesthesia | Severity(grading) of shivering | •Time to disappearance of shivering (minute) | •Time of recurrence (min)
•Time to disappearance of shivering (s)
时间窗: Time of onset of shivering (10minutes intervals) , after given spinal anesthesia | Severity(grading) of shivering | •Time to disappearance of shivering (minute) | •Time of recurrence (min)
•Time of recurrence (min)
时间窗: Time of onset of shivering (10minutes intervals) , after given spinal anesthesia | Severity(grading) of shivering | •Time to disappearance of shivering (minute) | •Time of recurrence (min)
次要结局
- Duration of surgery (min)(Duration of spinal anaesthesia (min))