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临床试验/NCT01734161
NCT01734161已完成4 期

A Prospective, Randomized, Double-Blinded Study to Evaluate the Efficacy of Intravenous Dexamethasone for Nausea Prophylaxis Prior to Duramorph and Bupivacaine Spinal Anesthesia for Scheduled Cesarean Section

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
122
试验地点
1
主要终点
Incidence of Post-operative Nausea and/or Vomiting

研究概览

简要总结

Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

详细描述

Women having cesarean sections commonly experience post-operative nausea and vomiting (PONV). This can be partly attributed to the long acting morphine (duramorph) given in the anesthetic (either through the epidural or in the spinal anesthetic). Intravenous dexamethasone is a widely used steroid medication with a well-established safety profile which is the standard of care for the prevention of PONV for general anesthesia in both adult and pediatric surgical patients. Many studies have shown that when intravenous dexamethasone is administered before duramorph in the epidural, the incidence of nausea and vomiting following cesarean section is significantly reduced. However, when patients receive intravenous dexamethasone after duramorph in a spinal anesthetic, it does not reduce the incidence of nausea and vomiting. There are not any published studies where dexamethasone was administered before a spinal anesthetic. The investigators believe that if dexamethasone is given intravenously before duramorph in a spinal anesthetic it may reduce the incidence of nausea and vomiting. Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-46 presenting for scheduled primary or repeat cesarean sections and have consented to study

排除标准

  • allergy to dexamethasone or morphine
  • history of gastrointestinal disease
  • history of severe nausea during pregnancy (hyperemesis gravidarum)
  • use of anti-emetic in the past 24 hours
  • history of gestational diabetes or diabetes mellitus
  • history of hypertension prior to or during pregnancy
  • presence of non-viable fetus

研究组 & 干预措施

Dexamethasone

Active Comparator

One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.

干预措施: Dexamethasone (Drug)

Placebo

Placebo Comparator

One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.

干预措施: Placebo (Drug)

结局指标

主要结局

Incidence of Post-operative Nausea and/or Vomiting

时间窗: 48 hours

The patient's self report of nausea and incidence of vomiting will be recorded intra-operatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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