Comparison of efficacy of IV Dexmedetomidine and IV Tramadol for management of post spinal shivering in LSCS surgeries. A prospective randomized double blind clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Time of cessation of shivering
研究概览
简要总结
In this study we are comparing efficacy of IV Tramadol Vs IVDexmedetomidine for shivering in LSCS surgery.
146 patients fulfilling our inclusion and exclusion criteriawill be randomly divided in 2 groups. In each group there will be 73 patientswho will be undergoing LSCS surgery. In group D, patients will receive 0.5 micrograms/kgIV Dexmedetomidine. In group T, patients will 0.5 mg/kg IV Tramadol.
Our primary aim is to assess time of cessation of shiveringduring the operation till 120 minutes after spinal anaesthesia. And oursecondary aim is to assess the time of onset of shivering, severity ofshivering, recurrence of shivering, hemodynamic stability and any side effect.Severity of Shivering will be assessed using a five-point scale proposed byCrossley and Mahajan.
This study can help identify the most effective treatmentand safety profile of IV Dexmedetomidine and IV tramadol for the management ofpost-spinal shivering in pregnant patients undergoing LSCS.
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
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients with shivering after giving spinal anesthesia in Caesarean section 2.Patients giving written and informed consent to participate in the study.
- •3.Age Group – 20 years to 45 years 4.American Society of Anesthesiologists (ASA) Grade II and III categories.
排除标准
- •1.Patients Refusal 2.Patient having shivering before giving spinal anesthesia 3.Pre-existing heart disease, Respiratory diseases, Patient with coagulation disorder
- •Intraoperative Bradycardia (20% decrease in baseline pulse rate ) or Hypotension (20% decrease in baseline MAP) 5.Patients with allergy to study drugs.
结局指标
主要结局
Time of cessation of shivering
时间窗: till 120 minutes after giving spinal anaesthesia
次要结局
- Onset of shivering(Severity of shivering)