NCT02384343已完成3 期
Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia: A Randomized Controlled Trial
St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time for cessation of shivering after bolus (min)
研究概览
简要总结
The purpose of this study is to determine whether dexmedotomidine is effective in the treatment of shivering associated with neuraxial anesthesia during cesarean delivery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cesarean delivery under neuraxial anesthesia (epidural or spinal) planned or unplanned between 8 am and 8 pm on week days when one of the investigator is present.
- •Participants with fever or shivering before the cesarean section are include
排除标准
- •No comprehension of french or english language
- •Urgent cesarean delivery for non reassuring fetal tracing
- •Extremely urgent cesarean delivery (grade 1)
- •Weight < 60 kg ou > 120 kg
- •Hypersensibility to dexmedetomidine
- •Heart, renal or hepatic disease requiring follow up, medication or with a possibility of instability during cesarean delivery
- •Pre-eclampsia
- •Combined spinal-epidural anesthesia
- •Conversion into general anesthesia
- •Blood products transfusions or major complications during surgery
研究组 & 干预措施
Dexmedetomidine
Active Comparator
Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus
干预措施: Dexmedetomidine (Drug)
Normal saline
Placebo Comparator
NaCl 0,9% 7,5 ml, single intravenous bolus
干预措施: Normal saline (Drug)
结局指标
主要结局
Time for cessation of shivering after bolus (min)
时间窗: Within the first 15 minutes of administration of bolus
Graded on a four point scale as per Crossley and Mahajan
次要结局
- Incidence of hypotension(From the administration of bolus to the end of surgery, an expected average of 1 hour)
- Incidence of bradycardia(From the administration of bolus to the end of surgery, an expected average of 1 hour)
- Incidence of sedation(From the administration of bolus to the end of surgery, an expected average of 1 hour)
研究者
Christina Lamontagne
MD
St. Justine's Hospital
研究点 (1)
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