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Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia

2026年9月30日 更新者:Tolga Karaçay、Sanliurfa Education and Research Hospital

Comparative Effectiveness of Routine Antiemetic Prophylaxis in Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia: A Prospective Randomized Controlled Trial

The aim of this prospective randomized double-blind study is to compare the effectiveness of routine antiemetic prophylaxis for the prevention of intraoperative nausea and vomiting (IONV) in non-fasted parturients undergoing emergency cesarean section under spinal anesthesia.

Nausea and vomiting are common complications during cesarean delivery performed under spinal anesthesia and may negatively affect maternal comfort and perioperative safety. The incidence of these symptoms may be particularly increased in emergency cesarean sections involving non-fasted (full-stomach) parturients. This study compares two commonly used antiemetic strategies, namely 5-hydroxytryptamine-3 (5-HT3) receptor antagonists and dopamine receptor antagonists, to determine their relative effectiveness in preventing IONV during surgery.

The findings are expected to contribute to optimization of antiemetic prophylaxis protocols, improvement of maternal comfort, and reduction of perioperative complications associated with nausea and vomiting during emergency cesarean delivery.

研究概览

详细说明

This prospective, randomized, double-blind clinical trial is designed to evaluate the comparative effectiveness of routine antiemetic prophylaxis for preventing intraoperative nausea and vomiting in non-fasted parturients undergoing emergency cesarean section under spinal anesthesia.

Eligible participants will be pregnant women with American Society of Anesthesiologists (ASA) physical status I-II who undergo emergency cesarean delivery under spinal anesthesia. Only non-fasted (full-stomach) parturients will be included.

Exclusion criteria include ASA physical status III or higher, preoperative anemia, massive intraoperative hemorrhage, requirement for additional intraoperative hypnotic agents, known gastrointestinal disease, psychiatric disorders or psychotropic medication use, and administration of antiemetic medication within 24 hours before surgery.

Participants will be randomized using a sealed-envelope allocation method before arrival in the operating room. Before transfer to the operating room, patients will receive the assigned study medication according to the randomization protocol. Both patients and the attending anesthesiologist responsible for outcome assessment will remain blinded to group allocation.

Participants will receive one of the following prophylactic antiemetic regimens:

Group O: 5-HT3 receptor antagonist (e.g., ondansetron or equivalent agent) Group M: Dopamine receptor antagonist (e.g., metoclopramide)

Standard monitoring will include electrocardiography, non-invasive blood pressure measurement, and peripheral oxygen saturation (SpO₂). Following intravenous cannulation, Ringer's lactate infusion will be initiated.

Spinal anesthesia will be performed at the L4-L5 interspace using 10 mg hyperbaric bupivacaine. After block placement, patients will be positioned supine with left uterine displacement to minimize aortocaval compression. Supplemental oxygen will be administered via nasal cannula at 2 L/min.

All participants will receive prophylactic intravenous ephedrine 5 mg. Additional 5 mg boluses will be administered if systolic blood pressure decreases below 100 mmHg or more than 20% from baseline values. Intravenous atropine 0.5 mg will be administered in cases of bradycardia (heart rate below 50-60 beats/min).

Following delivery of the fetal shoulders, oxytocin 20 IU will be administered intravenously as an infusion.

Demographic and perioperative data including age, body mass index, fasting duration since last solid food intake, smoking status, and operative duration will be recorded.

Hemodynamic variables (blood pressure and heart rate) will be recorded every 2 minutes until delivery and every 5 minutes thereafter until completion of surgery.

Intraoperative nausea and vomiting will be assessed during three predefined periods:

From 5 minutes after spinal anesthesia until delivery During and immediately after delivery From delivery until skin closure

Severity of nausea and vomiting will be evaluated using the Bellville scoring system:

0 = No nausea

  1. = Nausea
  2. = Retching (gagging)
  3. = Vomiting

Primary Outcome

Incidence of intraoperative nausea and vomiting occurring during and immediately after delivery.

Secondary Outcomes

Incidence and severity of intraoperative nausea and vomiting during the other predefined assessment periods.

Postoperative complications associated with antiemetic therapy

研究类型

介入性

注册 (估计的)

120

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Eyyübiye
      • Sanliurfa、Eyyübiye、土耳其(türkiye)、63040
        • 招聘中
        • Sanliurfa Education and Research Hospital
        • 接触:
        • 首席研究员:
          • Servet Sürmeli, M.D.
        • 副研究员:
          • Tolga Karaçay, M.D.
        • 副研究员:
          • Serkan Solak, M.D.
        • 副研究员:
          • Azer İlbengü Kaptan, M.D.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Pregnant women scheduled for emergency cesarean delivery under spinal anesthesia
  • Non-fasted (full-stomach) parturients
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Age ≥ 18 years
  • Singleton pregnancy
  • Ability to provide written informed consent

Exclusion Criteria:

  • ASA physical status III or higher
  • Refusal to participate
  • Elective cesarean delivery (non-emergency cases)
  • Preoperative antiemetic use within 24 hours before surgery
  • Known allergy or contraindication to study drugs (ondansetron or metoclopramide)
  • Pre-existing gastrointestinal disorders (e.g., severe GERD, gastroparesis, bowel obstruction)
  • Psychiatric illness or current use of psychotropic medications
  • Preoperative anemia (as defined by institutional threshold, e.g., Hb < 10 g/dL)
  • Intraoperative conversion to general anesthesia
  • Massive intraoperative hemorrhage (>1000-1500 mL or requiring transfusion, depending on your protocol definition)
  • Intraoperative administration of additional sedative or antiemetic agents outside study protocol
  • Multiple gestation pregnancies

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:5-HT3 Receptor Antagonist Group

Participants undergoing emergency cesarean delivery under spinal anesthesia will receive prophylactic administration of a 5-HT3 receptor antagonist before surgery. Intraoperative and early postoperative nausea and vomiting will be assessed.

Prophylactic intravenous administration of a 5-HT3 receptor antagonist prior to cesarean delivery under spinal anesthesia.

实验性的:Dopamine Receptor Antagonist Group

Participants undergoing emergency cesarean delivery under spinal anesthesia will receive prophylactic administration of a dopamine receptor antagonist before surgery. Intraoperative and early postoperative nausea and vomiting will be assessed.

Prophylactic intravenous administration of a dopamine receptor antagonist prior to cesarean delivery under spinal anesthesia.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery
大体时间:Perioperative

Incidence of nausea, retching, or vomiting occurring during the immediate period following fetal delivery, assessed using the Bellville scoring system. From fetal delivery until uterine closure.

Perioperative

次要结果测量

结果测量
措施说明
大体时间
Incidence of Intraoperative Nausea and Vomiting Between Spinal Anesthesia and Fetal Delivery
大体时间:Perioperative

Incidence of nausea, retching, or vomiting occurring from initiation of spinal anesthesia until fetal delivery.From spinal anesthesia administration until fetal delivery.

Perioperative
Incidence of Intraoperative Nausea and Vomiting Immediately Before Fetal Delivery
大体时间:Perioperative

Incidence of nausea, retching, or vomiting occurring in the late intraoperative period immediately preceding fetal delivery. From uterine incision to fetal delivery

Perioperative
Incidence of Intraoperative Nausea and Vomiting During Skin Closure
大体时间:Perioperative

Incidence of nausea, retching, or vomiting occurring during surgical skin closure.

Perioperative
Postoperative Complications Related to Antiemetic Prophylaxis
大体时间:Postoperative

Incidence of adverse effects associated with prophylactic antiemetic agents including headache, dizziness, hypotension, extrapyramidal symptoms, or sedation. From end of surgery through 24 hours postoperatively.

Postoperative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月30日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月2日

研究注册日期

首次提交

2026年7月27日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年7月31日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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