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NCT07740577

Overview

NCT ID: NCT07740577
Lead Sponsor: Sanliurfa Education and Research HospitalOTHER_GOV
Official Title: Comparative Effectiveness of Routine Antiemetic Prophylaxis in Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia: A Prospective Randomized Controlled Trial
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.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
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