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临床试验/NCT05692245
NCT05692245已完成4 期

Dexamethasone vs Ondansetron as the First-line Antiemetic to Prevent Postoperative Nausea and Vomiting After Cesarean Delivery

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月30日最近更新:
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
100
试验地点
1
主要终点
Medications Received

研究概览

简要总结

The goal of this clinical trial is to compare medications in women having a cesarean delivery. The main question it aims to answer are:

• Which medication is better to use as a first-line prevention agent for nausea and vomiting Participants will rate their nausea, pain and other symptoms after surgery Researchers will compare two drugs, ondansetron and dexamethasone to see if the side effects of pain medications are improved after cesarean.

详细描述

Cesarean delivery is the most common surgical procedure performed in the United States, with approximately 1.2 million cesarean deliveries performed in 2020.(1) Cesarean delivery is preferentially performed under neuraxial anesthesia (spinal or epidural anesthesia) to allow mothers to be awake during the delivery of their child and to improve maternal safety. Despite the routine use of neuraxial techniques for most cesarean deliveries in the United States, many patients experience nausea and/or vomiting either during surgery (intraoperative nausea and vomiting, IONV) or after surgery (postoperative nausea and vomiting, PONV).

PONV has traditionally been associated with female gender, history of motion sickness, nonsmoking status, and opioid use.(2) Other authors have shown increased PONV risk with younger age, type of surgery, and general anesthesia as opposed to regional or neuraxial anesthesia.(3,4) Intrathecal opioids, are the gold standard for pain relief after cesarean delivery, and are part of the Society for Obstetric Anesthesia and Perinatology's (SOAP) Early Recover After Cesarean (ERAC) guideline. However, these medications have been implicated in increased rates of PONV.(5) Given the prevalence of cesarean delivery and the importance of maternal well-being, prophylaxis of nausea and vomiting remains an important issue to address.

Medications from multiple classes are commonly administered to prevent and treat PONV after cesarean delivery. These include 5-HT3 antagonists, dopaminergic antagonists, corticosteroids, antihistamines, and anticholinergics. Ondansetron, a 5HT3 antagonist, and dexamethasone, a corticosteroid, are among the most commonly administered medications due to their efficacy and long track record of safety during pregnancy. Indeed, the SOAP ERAC guideline recommends that at least two agents from different classes be administered perioperatively to decrease the rates of IONV and PONV.(6) They further suggest metoclopramide for IONV prophylaxis, ondansetron or dexamethasone for PONV prophylaxis.

The safety and efficacy of ondansetron and dexamethasone are further supported by a 2021 Cochrane Systematic review analyzing medical prophylaxis against IONV and PONV in cesarean delivery.(6) Both ondansetron and dexamethasone decreased postoperative nausea (Ond: RR 0.45; 10 RCT, 1340 total subjects; Dex: RR 0.59; 6 studies, 733 women) and vomiting rates (Ond: RR 0.47, 10 studies, 1450 women; Dex: RR 0.68; 7 RCT, 793 women). No adverse events from 5HT3 blocking agents or corticosteroids were identified.

Dexamethasone is intriguing as a first-line agent for cesarean delivery since it may have the added benefit of improved pain control and/or decreased postoperative opioid requirement. Several studies have addressed the role of dexamethasone in pain management. A 2008 study by Jaafarpour et al.(8) found a decrease in composite rates of nausea and vomiting, as well reduction of ~1 point on the VAS pain scale for 24 hours following surgery. Data from other studies have been mixed (9, 10, 11).

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)

盲法说明

Randomized assignment maintained in a sealed envelop. Study medication provided by a independent party. Investigators remain blinded until completion of analysis.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy women (ASA 2)
  • Between 18 and 45 years old
  • Singleton term pregnancies
  • Scheduled or non-labor cesarean delivery
  • Neuraxial (spinal or combined-spinal epidural) anesthesia

排除标准

  • Refusal to participate
  • Known allergy or contraindication to any medication used in the study
  • Significant medical or obstetrical disease (ASA ≥ 3)
  • Antiemetic use within 24 hours preceding cesarean delivery
  • Insulin dependent diabetes
  • Hyperemesis gravidarum or chronic antiemetic use
  • History of daily or near-daily steroid use during pregnancy
  • Opioid use disorder or other chronic pain syndrome
  • Opioid use during pregnancy
  • Use of antipruritus medication, pruritic urticarial papules of pregnancy, or cholestasis of pregnancy

研究组 & 干预措施

Ondansetron

Active Comparator

ondansetron 4 mg intravenous, given once after initiation of anesthesia

干预措施: Ondansetron (Drug)

Dexamethasone

Active Comparator

dexamethasone 8 mg intravenous, given once after initiation of anesthesia

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Medications Received

时间窗: 24 hours

Total number of unscheduled medications administered by nurses to patients and received in the 24 hours after cesarean for the treatment of Nausea, vomiting, pruritus or pain

次要结局

  • Severity of Pain(24 hours)
  • Severity of Nausea(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phillip Hess

Staff

Beth Israel Deaconess Medical Center

研究点 (1)

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