Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Clinically Controlled Dose-finding Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Shivering response rate (%)
研究概览
简要总结
This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.
详细描述
Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression.
Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of >60 and <180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period
排除标准
- •Patients with BMI>30 kg /m2
- •Initial body temperature >38 C or <36 C and those with a history of convulsions
- •Multiple allergies
- •Thyroid disease
- •Parkinson's disease
- •Dysautonomia
- •Raynaud's syndrome
- •Hypertension
- •Coronary artery disease or other cardio-respiratory or neuromuscular pathology
- •Middle ear pathology
- •A known history of alcohol use
- •Treatment with sedative hypnotic agents or vasodilators
- •Having contraindications to spinal anesthesia
研究组 & 干预措施
Pethidine 0.4mg/kg iv
interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished.
干预措施: Pethidine 0.4mg/kg (Drug)
DEX. I
Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished.
干预措施: Dexmedetomidine (Drug)
DEX. II
Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.
干预措施: Dexmedetomidine (Drug)
DEX III
Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Shivering response rate (%)
时间窗: 10 minutes
complete cessation of shivering activity within 10 minutes after study drug injection
次要结局
- sedation(6 hours after study drug injection)
- Systolic blood pressure(6 hours after study drug injection)
- Postoperative adverse events(24 hours postoperative)
- peripheral arterial saturation(6 hours after study drug injection)
- diastolic blood pressure(6 hours after study drug injection)
研究者
Hala Saad Abdel-Ghaffar
Assistant professor in anesthesia department, faculty of medicine, Assiut university
Assiut University