A prospective randomised double-blind comparative study between intravenous clonidine And dexmedetomidine for post-spinal anaesthesia shivering
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- We will compare the effects of clonidine and dexmedetomidine on shivering in terms of time of cessation of shivering,
研究概览
简要总结
The aim of this study is to evaluateand compare the efficacy, haemodynamics and adverse effects of dexmedetomidinewith those of clonidine, when used for control of post spinal anaesthesiashivering during the intraoperative period. 54 American Society of Anaesthesiologistgrade I and II patients of either sex, aged 18-60 years, scheduled forsurgeries under spinal anaesthesia will be randomised into two groups of 27patients each. One group will receive dexmedetomidine 0.5mcg/kg , other groupwill receive clonidine 0.5mcg/kg. Grade of shivering, time of cessation ofshivering, response rate, recurrence rate and adverse effects will beobserved at scheduled intervals.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age- 18-60 years
- •ASA grade 1 & 2
- •OT temp between 24 to 32 degree
- •Gynaecology and obstetrics, surgery, and orthopaedic operations.
排除标准
- •Preexisting cardiac diseases
- •Pulmonary diseases
- •Bleeding or coagulation disorders
- •Renal or hepatic disease
- •Neuromuscular disorder
- •Psychiatric disorder
- •Hyperthyroidism
- •Deformity of the spinal column
- •Urinary tract infection 10.Severe diabetes or autonomic neuropathies 11.Known history of substance or alcohol abuse 12 Patient receiving any premedication 13.Cutaneous infection 14.Contraindication of spinal anaesthesia 15.Conversion to GA at any time intraoperatively 16.Patient refusal.
结局指标
主要结局
We will compare the effects of clonidine and dexmedetomidine on shivering in terms of time of cessation of shivering,
时间窗: At baseline and at intervals of every 5 min for first 30 min and every 15 min for rest of the observation period after starting point of shivering.
response rate and recurrence rate of shivering following spinal anaesthesia
时间窗: At baseline and at intervals of every 5 min for first 30 min and every 15 min for rest of the observation period after starting point of shivering.
次要结局
- We will observe the change in blood pressure, heart rate, respiratory depression, nausea vomiting, dry mouth, effect of sedation in patients who will receive clonidine and dexmedetomidine separately.(At baseline and at intervals of every 5 min for first 30 min and every 15 min for rest of the observation period after starting point of shivering.)