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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Ondansetron 4mg
DrugProphylactic intravenous administration of a 5-HT3 receptor antagonist prior to cesarean delivery under spinal anesthesia.
metoclopramide
DrugProphylactic intravenous administration of a dopamine receptor antagonist prior to cesarean delivery under spinal anesthesia.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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
Incidence of Intraoperative Nausea and Vomiting During Skin Closure
Incidence of nausea, retching, or vomiting occurring during surgical skin closure.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.