Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07740577

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sanliurfa Education and Research Hospital

Sanliurfa, Eyyübiye, 63040, Turkey (Türkiye)

Location contact

Azer İlbengü Kaptan, M.D.

SUB_INVESTIGATOR

Serkan Solak, M.D.

SUB_INVESTIGATOR

Servet Sürmeli, M.D.

PRINCIPAL_INVESTIGATOR

Tolga Karaçay

CONTACT

[email protected]

05458718351

Tolga Karaçay, M.D.

SUB_INVESTIGATOR

About this study

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

  • = Nausea
  • = Retching (gagging)
  • = 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ondansetron 4mg

Drug

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

Metoclopramide

Drug

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

Primary outcomes

  1. Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery

    Time frame: 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.

Secondary outcomes

  1. Incidence of Intraoperative Nausea and Vomiting Between Spinal Anesthesia and Fetal Delivery

    Time frame: Perioperative

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

  2. Incidence of Intraoperative Nausea and Vomiting Immediately Before Fetal Delivery

    Time frame: Perioperative

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

  3. Incidence of Intraoperative Nausea and Vomiting During Skin Closure

    Time frame: Perioperative

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

  4. Postoperative Complications Related to Antiemetic Prophylaxis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tolga Karaçay

CONTACT

[email protected]

+905458718351

Sponsors and collaborators

Lead sponsor

Sanliurfa Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.