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

NCT07740577 | Not Yet Recruiting Phase 4

• 1 other identifier: HRÜ/26.07.15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Nausea-retching-vomiting Episodes; Spinal Aneshtesia; Ceserean Section; Antiemetic Therapy; Ondansetron; Metoclopramide

Keywords

Cesarean Section; Emergency Cesarean Delivery; Non-fasted Parturients; Full Stomach; Spinal Anesthesia; Antiemetic Prophylaxis; Intraoperative Nausea and Vomiting; Obstetric Anesthesia; Maternal Outcomes

Outcome Measures

Primary Outcomes (1)

• Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery

  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

Secondary Outcomes (4)

• Incidence of Intraoperative Nausea and Vomiting Between Spinal Anesthesia and Fetal Delivery

  Perioperative

• Incidence of Intraoperative Nausea and Vomiting Immediately Before Fetal Delivery

  Perioperative

• Incidence of Intraoperative Nausea and Vomiting During Skin Closure

  Perioperative

• Postoperative Complications Related to Antiemetic Prophylaxis

  Postoperative

Study Arms (2)

5-HT3 Receptor Antagonist Group

EXPERIMENTAL

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.

Drug: Ondansetron 4mg

Dopamine Receptor Antagonist Group

EXPERIMENTAL

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.

Drug: metoclopramide

Interventions

Ondansetron 4mg DRUG

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

5-HT3 Receptor Antagonist Group

metoclopramide DRUG

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

Dopamine Receptor Antagonist Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

Study Sites (1)

Sanliurfa Education and Research Hospital

Sanliurfa, Eyyübiye, 63040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vomiting

Interventions

Ondansetron; Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Central Study Contacts

Tolga Karaçay

CONTACT

+905458718351; tkaracay35@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Participants will be randomly assigned to one of two parallel groups receiving routine prophylactic antiemetic treatment before emergency cesarean delivery under spinal anesthesia. One group will receive a 5-HT3 receptor antagonist, whereas the other group will receive a dopamine receptor antagonist. Outcomes will be compared between groups during the intraoperative and early postoperative periods.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 31, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 2, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

TU (1)