NCT07740577 Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia
| NCT ID | NCT07740577 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sanliurfa Education and Research Hospital |
| Condition | Intraoperative Nausea-retching-vomiting Episodes |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-07-30 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2026-07-30 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07740577 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Intraoperative Nausea-retching-vomiting Episodes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07740577 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07740577 currently recruiting?
Yes, NCT07740577 is actively recruiting participants. Contact the research team at tkaracay35@gmail.com for enrollment information.
Where is the NCT07740577 trial being conducted?
This trial is being conducted at Sanliurfa, Turkey (Türkiye).
Who is sponsoring the NCT07740577 clinical trial?
NCT07740577 is sponsored by Sanliurfa Education and Research Hospital. The trial plans to enroll 100 participants.