Dexmedetomidine for Treatment of Shivering During Scheduled Elective Cesarean Delivery: Determining the Optimal Dose
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan
研究概览
简要总结
The purpose of this study is to determine the optimum dose of Dexmedetomidine to stop shivering in 90% of patients who experience shivering during scheduled elective cesarean deliveries.
详细描述
Potential subjects will consist of parturients who present for scheduled elective cesarean deliveries. Patients will be recruited and consented for the study pre-operatively and if they display Grade 3 or 4 shivering at the time of delivery then they will be enrolled in the study. Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect - cessation of shivering within 5 minutes of medication administration. An anesthesia physician not involved in patient care or assessment will prepare the dexmedetomidine for intravenous use. Anesthesia will be initiated with spinal anesthesia with our institution's typical dosing of 1.6 mL 0.75% bupivacaine with dextrose, 15 mcg fentanyl, and 150 mcg morphine.
Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan. Members of the anesthesia team caring for women in the study will be educated on the grading scales.
- Grade 0: no shivering;
- Grade 1: one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis, but without visible muscle activity; Grade 2: visible muscle activity confined to one muscle group;
- Grade 3: visible muscle activity in more than one muscle group;
- Grade 4: gross muscle activity involving the whole body
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Women presenting for planned cesarean delivery.
- •American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.
- •Singleton gestation in the 3rd trimester (28-42 weeks gestation).
- •Spinal anesthesia technique Women presenting for planned cesarean delivery.
- •American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.
- •Singleton gestation in the 3rd trimester (28-42 weeks gestation).
- •Spinal anesthesia technique.
排除标准
- •Any contraindication to spinal anesthesia technique.
- •Allergy or intolerance to dexmedetomidine or clonidine.
- •Oral temperature < 36° Celsius prior to procedure.
- •Unable to give personal consent.
- •PPROM or concern for infection (e.g., chorioamnionitis).
- •Conversion to General Anesthesia prior to randomization.
- •Sedative medications (e.g., fentanyl, midazolam, ketamine, nitrous oxide) administered prior to randomization.
研究组 & 干预措施
Dexmedetomidine
IV administration of Dexmedetomidine, using an Up-Down method utilizing a biased coin design to determine that next patient's dose. Initial dose will be 10mcg.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan
时间窗: 5 minutes after administration of the drug
Cessation of shivering
次要结局
- Doses of dexmedetomidine(During intraoperative course)
- Maternal Heart Rate(During intraoperative course)
研究者
Hans P. Sviggum, M.D.
Principal Investigator
Mayo Clinic