Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Shivering measured by Visual analogue score
研究概览
简要总结
This is a randomized double blinded trial to determine if a small dose of dexmedetomidine can prevent and relieve nausea and shivering, two of the more common complaints after cesarean delivery.
详细描述
This study is a randomized, placebo controlled, double blind evaluation of the use of a single dose of dexmedetomidine for the prevention of shivering and nausea after cesarean delivery. It is hypothesized that patients who receive dexmedetomidine (as compared to placebo) will have a reduced severity of postoperative shivering and nausea.
Study subjects will be have a scheduled cesarean section. They will receive written, informed consent obtained before surgery. After enrollment, patients will receive spinal anesthesia consisting of 11.25mg bupivacaine, 25 mcg of fentanyl, and 250 mcg of morphine. All IV fluid will be warmed.
After delivery of the neonate, delivery of the placenta, and assurance of adequate uterine tone, patients will be randomized in a 1:1 fashion to receive a blinded study syringe consisting of either placebo saline, or 10 mcg of dexmedetomidine.
Study outcomes will be measured on an 11-point Likert scale assessing shivering, nausea, pain, pruritus, and sedation. Assessments will be performed on admission to the recovery room, and at 30 and 60 minutes.
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
Study medication provided in blinded syringe labeled with study number
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective cesarean delivery
- •≥ 18 years of age
- •Singleton pregnancy
- •Term delivery (37 weeks or greater gestation)
- •Spinal or combined spinal-epidural anesthesia is planned
排除标准
- •Non-elective cesarean delivery
- •Receiving misoprostil or carboprost
- •Postpartum hemorrhage greater that 1000cc
- •Chronic opioid use
- •History of chronic nausea or itching in pregnancy
- •Receiving medications for nausea
- •Inability to provide written informed consent
- •Receiving of any of the following medications intraoperatively: misoprostil, carboprost, medications for nausea
- •Postpartum hemorrhage greater that 1000cc
研究组 & 干预措施
Dexmedetomidine
Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection
干预措施: Dexmedetomidine (Drug)
Placebo
Patient will receive 5 ml of normal saline, administered by slow intravenous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Shivering measured by Visual analogue score
时间窗: 60 minutes
Severity of patient shivering measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Postoperative nausea and vomiting measured by Visual analogue score
时间窗: 60 minutes
Severity of postoperative nausea and vomiting measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
次要结局
- Pruritus measured by Visual analogue score(60 minutes)
- Sedation measured by Visual analogue score(60 minutes)
- Pain measured by Visual analogue score(60 minutes)
- Dry mouth measured by Visual analogue score(60 minutes)
研究者
Phillip Hess
Staff Anesthesiologist
Beth Israel Deaconess Medical Center