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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSanliurfa Education and Research Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

ASA physical status III or higher

Refusal to participate

Elective cesarean delivery (non-emergency cases)

Preoperative antiemetic use within 24 hours before surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: 5-HT3 Receptor Antagonist GroupExperimental treatment 1 intervention
Group B: Dopamine Receptor Antagonist GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Perioperative

Secondary outcomes

1

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

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

Time frame
Perioperative
2

Incidence of Intraoperative Nausea and Vomiting Immediately Before Fetal Delivery

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

Time frame
Perioperative
3

Incidence of Intraoperative Nausea and Vomiting During Skin Closure

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

Time frame
Perioperative
4

Postoperative Complications Related to Antiemetic Prophylaxis

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.

Time frame
Postoperative

Other outcomes

Sponsors and contacts

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