Traitement Des Frissons Lors de la césarienne Sous anesthésie péridurale Durant le Travail - un Essai Clinique randomisé Comparant la dexmédétomidine et la mépéridine
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
- Stop time
研究概览
简要总结
Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.
详细描述
It is a double blinded randomized control trial.
Study population: parturients undergoing a cesarean delivery for labor dystocia under epidural anesthesia experiencing shivering grade III or IV on the standardized shivering scale of Crossley and Mahajan
Experimental group: dexmedetomidine 0.35 mcg/kg IV in 2 minutes
Control group: meperidine 0.35 mg/kg IV in 2 minutes
Primary outcome : Time to stop level III and IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug
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)
盲法说明
Double-blinded randomized study: meperidine and dexmedetomidine will be prepared at the hospital pharmacy in a 10 mL seringue with equivalent dilution in order to gave mL/kg.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Term > 37 weeks
- •American Society of Anesthesiologists Physical Status (ASA PS) I, II
- •Weight < 115 kg
- •Functional epidural in situ
- •In labor requiring cesarean delivery
- •Class III or IV shivering on the Crossley and Mahajan standardized shivering scale between five minutes after the baby's birth to the end of the cesarean section
排除标准
- •Refusal of the patient and/or the anesthesiologist
- •Misunderstanding of the protocol
- •Known allergy or contraindication to one of the study drugs
- •Emergency cesarean delivery
- •American Society of Anesthesiologists Physical Status III, IV, V
- •Severe heart, liver or kidney disease,
- •Preeclampsia
- •Patient taking monoamine oxydase inhibitors
- •Sleep apnea
- •General anesthesia
研究组 & 干预措施
dexmedetomidine
Unique dose of dexmedetomidine injection:
- intravenous injection
- 0.35 mcg/kg
- in two minutes
- if shivering 5 minutes after delivery
干预措施: Dexmedetomidine Injection (Drug)
meperidine
Unique dose of meperidine injection:
- intravenous injection
- 0.35 mg/kg
- in two minutes
- if shivering 5 minutes after delivery
干预措施: Meperidine Injection (Drug)
结局指标
主要结局
Stop time
时间窗: 15 minutes
Time to stop class III or IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug (meperidine versus dexmedetomidine)
次要结局
- incidence of adverse effects(24 hours)
- maternal satisfaction(at 24 hours)
- response rate(15 minutes)
- cost benefice analysis(24 hours)