A comparative study to determine the efficacy of dexmedetomidine and nalbuphine for the treatment intraoperative shivering in the patients posted for surgery Under spinal anaesthesia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To determine the efficacy of dexmedetomidine and nalbuphine in the treatment of
研究概览
简要总结
Introduction: Shivering is commonly observed in patients following subarachnoid block. Dexmedetomidine is an alpha 2 adrenergic receptor agonist has been observed to decrease the incidence of shivering in post spinal anaesthesia patients. Nalbuphine is a synthetic opioid which has both agonist antagonist activity and is commonly used in treatment of post spinal shivering.
Aim: This study aims to compare, dexmedetomidine and nalbuphine in terms of clinical efficacy for the treatment of shivering in the patients scheduled for surgery under spinal anaesthesia.
**Material And Method:**This randomized control trial shall be conducted in 90 patients posted for surgery under spinal anaesthesia. Patients would be further allocated into three groups, group A (dexmedetomidine), group B (nalbuphine) and group C (placebo), each group comprising of 30 patients each. Shivering will be graded according to the Bedside Shivering Assessment Score (BSAS). Time of onset of shivering, severity of shivering, time to cessation of shivering, time of reoccurrence and side effects will be noted.
Conclusion: The data generated from this study will be compiled and analyzed according to appropriate statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade 1 and 2.
排除标准
- •a) Allergic to any of the drugs b) Contraindication to spinal anaesthesia c) Obese patients BMI more than 30 d) ASA grade 3 and 4 e) Patients with coagulopathy, heart blocks and bradycardia, f) Pregnant and nursing mothers.
结局指标
主要结局
To determine the efficacy of dexmedetomidine and nalbuphine in the treatment of
时间窗: Start from the initiation of anaesthesia till the end of surgery at every 5 min in first half hour and every 15 min till the end of surgery
intraoperative shivering in the patients scheduled for surgery under spinal anaesthesia
时间窗: Start from the initiation of anaesthesia till the end of surgery at every 5 min in first half hour and every 15 min till the end of surgery
次要结局
- 1) Time for cessation of shivering in (min) following drug administration(2) Grade of shivering following drug administration.)
研究者
Dr Anita Kumari
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar