CTRI/2021/03/032090尚未招募不适用
Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering
Dr DYPatil Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- cessation of shivering , Episodes of recurrence
研究概览
简要总结
To compare efficacy of dexmedetomidine versus tramadol for control of post-spinal anaesthesia shivering.
To compare the perioperative variations in hemodynamic parameters and the incidence of adverse effects among the groups.
Dexmedetomidine (α2 adrenergic agonist) has been used for prevention of post anaesthesia shivering. Its use for the treatment of post-spinal anaesthesia shivering has not been evaluated. The aim of this study is to evaluate and compare the efficacy, haemodynamic and adverse effects of dexmedetomidine with those of tramadol, when used for control of post-spinal anaesthesia shivering.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •>Patient giving consent >patients of either gender aged 18-65 years scheduled for elective lower abdominal, lower limb surgeries under spinal anaesthesia >American Society of Anesthesiologist physical status class I and II.
排除标准
- •â€¢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.
- •â€¢cesarean section.
结局指标
主要结局
cessation of shivering , Episodes of recurrence
时间窗: shivering ceasing within 15 min after treatment , time of recurrence after treatment
次要结局
- Adverse effects such as nausea, vomiting, bradycardia (50/min), hypotension (20% of baseline), dizziness; and sedation score will be noted. The degree of sedation will be graded on a four-point scale as Grade 1: Awake and alert, Grade 2: Drowsy, responsive to verbal stimuli, Grade 3: Drowsy, arousable to physical stimuli, Grade 4: Unarousable(every 15 min interval hemodynemic changes)
研究者
研究点 (1)
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