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

30 september 2026 bijgewerkt door: Tolga Karaçay, Sanliurfa Education and Research Hospital

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

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.

Studie Overzicht

Gedetailleerde beschrijving

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

  1. = Nausea
  2. = Retching (gagging)
  3. = 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

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Eyyübiye
      • Sanliurfa, Eyyübiye, Turkije (Türkiye), 63040
        • Werving
        • Sanliurfa Education and Research Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Servet Sürmeli, M.D.
        • Onderonderzoeker:
          • Tolga Karaçay, M.D.
        • Onderonderzoeker:
          • Serkan Solak, M.D.
        • Onderonderzoeker:
          • Azer İlbengü Kaptan, M.D.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 5-HT3 Receptor Antagonist Group

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.

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

Experimenteel: Dopamine Receptor Antagonist Group

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.

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Intraoperative Nausea and Vomiting Immediately After Fetal Delivery
Tijdsspanne: 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.

Perioperative

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Intraoperative Nausea and Vomiting Between Spinal Anesthesia and Fetal Delivery
Tijdsspanne: Perioperative

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

Perioperative
Incidence of Intraoperative Nausea and Vomiting Immediately Before Fetal Delivery
Tijdsspanne: Perioperative

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

Perioperative
Incidence of Intraoperative Nausea and Vomiting During Skin Closure
Tijdsspanne: Perioperative

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

Perioperative
Postoperative Complications Related to Antiemetic Prophylaxis
Tijdsspanne: 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.

Postoperative

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juli 2026

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

2 januari 2027

Studieregistratiedata

Eerst ingediend

27 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 juli 2026

Eerst geplaatst (Werkelijk)

31 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

30 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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