Randomised double blind comparitivestudy of intravenous nalbuphine and tramadol for post-spinal anaesthesia shivering
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.To compare the effectiveness of intravenous nalnupine and tramadol for post spinal anaesthesia shivering.
研究概览
简要总结
Background and Aims: The present study designed to compare theclinical efficacy, hemodynamic and side effects of nalbuphine and tramadol,when used for control of post‑spinal anesthesia shivering.
Methods: A prospective, randomised, and double‑blind study was conducted in 90 American Society of AnesthesiologistsGrade I and II patients of either gender, aged between 18-60 years, whosubsequently developed shivering grade 3 or 4, scheduled for various surgicalprocedures under spinal anesthesia. The patients were randomized into two groups of 45 patients each toreceive either nalbuphine 0.06 mg/kg (Group N) or tramadol 1 mg/kg (Group T). Grade of shivering, onset of shivering, time intervalfor cessation of shivering, response rate at 5 min and 30 min, rescue dose,hemodynamic parameters and adverse effects were observed at scheduledintervals. Independent t‑test was used for analysing the data.
Results: Time taken for cessation of shivering was significantly less with nalbuphinewhen compared to tramadol (p<0.05).Itwas observed that the response time at 5 min and 30 min and rescue doserequirement for control of shivering was not much difference (p>0.05).However, sedation was significantly more in the nalbuphine group and tramadol significantlycauses more nausea and vomiting.
Conclusion: Bothnalbuphine (0.06 mg/kg) and tramadol (1 mg/kg) are effective in treatingpatients with post‑spinalanesthesia shivering. However, the time taken for cessation of shivering is significantly less with nalbuphinewhen compared to tramadol. Furthermore, tramadol causes significantly morenausea and vomiting, however, nalbuphine causes significantly more sedation.
Key words: Nalbuphine,post‑spinal anesthesia shivering, 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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of ASA physical status I &II 2.Age between 18-50 yrs of age of either sex who have undergone routine general, orthopaedic, or gynaecological and obstetrical surgery under spinal anaesthesia.
- •3.Post anaesthetic shivering occurring within 10min of admission to recovery room.
排除标准
- •1.<18 yrs of age& >50 yr of age 2.Post anaesthetic shivering occurring after 10 min of admission to recovery room 3.Known hyperthyroidism, cardiopulmonary or neuromuscular pathology 4.Patients with contraindication for the use of Nalbuphine and Tramadol will not be included.
结局指标
主要结局
1.To compare the effectiveness of intravenous nalnupine and tramadol for post spinal anaesthesia shivering.
时间窗: 0min,5min,10min,15min,20min,25min,30min
次要结局
- 1.To study the adverse effects if any.(2.To compare any haemodynamic changes)