A comparative study of Dexmedetomidine and tramadol for the treatment of post-spinal anaesthesia shivering
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cessation of shivering
研究概览
简要总结
Post-spinal anaesthesia shivering is a frequent complication which can endanger the haemodynamic stability and recovery of patients. A number of drugs are being used out of which tramadol is an established agent. However, there is no ideal anti-shivering agent as the use of available drugs is associated with various adverse effects. The anti-shivering potential of dexmedetomidine is being explored recently in various trials which indicati it to be efficacious as well as free from any major adverse effect. We plan to do a randomised, controlled clinical study to compare the efficacy, potency, adverse and haemodunamic effects of tramadol and dexmedetomidine in 50 patients after IEC approval and written informed consent from each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •50 ASA grade-l & II patients of either gender aged 18 to 65 years scheduled for elective as well as emergency lower abdominal, lower limb, orthopaedic and plastic surgeries under spinal anaesthesia were included in the study.
排除标准
- •Patients with known hypersensitivity to Dexmedetomidine or Tramadol, cardio-pulmonary, renal or hepatic disease, hyperthyroidism, psychiatric disorder, urinary tract infection, severe diabetes or autonomic neuropathies, known history of substance or alcohol abuse, patients receiving any pre-medication were not be included in the study.
结局指标
主要结局
Cessation of shivering
时间窗: time of cessation of shivering
次要结局
- level of sedation(intra and post-operative)