Ireland
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Recruiting Phase 4

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

NCT07740577 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 4
Started
2026-07-30
Last updated
2026-10-01

Condition(s) studied

Intraoperative Nausea-retching-vomiting EpisodesSpinal AneshtesiaCeserean SectionAntiemetic TherapyOndansetronMetoclopramide

Investigational drug(s) / intervention(s)

Ondansetron 4mg →metoclopramide →

Ondansetron 4mg: Prophylactic intravenous administration of a 5-HT3 receptor antagonist prior to cesarean delivery under spinal anesthesia.

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

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery — 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.

Trial sites (1)

FacilityCityRegionStatus
Sanliurfa Education and Research Hospital Sanliurfa Eyyübiye Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07740577 on ClinicalTrials.gov ↗ ← All trials in Turkey