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IRCT20260425069157N1 IRCT 2026-04-28 Oroumia University of Medical Sciences Effects of Metoclopramide and Ondansetron on Post‑Cesarean Nausea and Vomiting A Comparison of the Efficacy of Metoclopramide and Ondansetron in Reducing Nausea and Vomiting during Spinal Anesthesia for Elective Cesarean Section 2026-05-22 anticipated 140 Recruiting https://irct.ir/trial/89660 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomized using block randomization with fixed block sizes of four. The random allocation sequence will be generated by computer software, and within each block, patients will be randomly assigned to either Group A or Group B. To prevent selection bias, allocation concealment will be ensured using the SNOSE method (Sequentially Numbered, Opaque, Sealed Envelopes). The random sequence will be placed inside opaque, sequentially numbered, sealed envelopes, which will be opened only after participant enrollment, Blinding description: To maintain blinding, both medications (metoclopramide and ondansetron) are clear, colorless injectable solutions and are indistinguishable in appearance, volume, and method of administration. The medications will be prepared by an independent person in identical unlabelled syringes and coded as A/B. Therefore, both participants and outcome assessors will remain unaware of the allocated intervention, ensuring effective blinding at both participant and assessor levels. 3 Elective cesarean section. Intervention 1: Ten milligrams of injectable metoclopramide (10 mg/2 mL ampoule, Sina Darou Pharmaceutical Co., Iran) diluted with normal saline to a final volume of 5 mL will be administered intravenously over 30–60 seconds, 5 minutes before spinal anesthesia. The final volume, timing, injection rate, and all anesthesia-related conditions will be identical in both groups. Intervention 2: Four milligrams of injectable ondansetron (4 mg/2 mL ampoule, Actoverco Pharmaceutical Co., Iran) diluted with normal saline to a final volume of 5 mL will be administered intravenously over 30–60 seconds, 5 minutes before spinal anesthesia. All injection conditions and anesthesia protocols will match those of the metoclopramide group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I will make a decision to publish after the completion of the project and according to the results
public Dr. Roghayea Neisari
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 0998 nisari.r@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Roghayea Neisari
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
Urmia Iran (Islamic Republic of) 5715859497 +98 44 3346 0998 nisari.r@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Age 18–40 years Willingness to participate and providing informed consent Singleton pregnancy undergoing elective cesarean section ASA physical status class I–II 18 years 40 years Female Withdrawal of consent at any stage of the study Known hypersensitivity to metoclopramide, ondansetron, or any component of their formulations Development of drug-related adverse effects O82 Encounter for cesarean delivery without indication Treatment - Surgery Treatment - Surgery Ten milligrams of injectable metoclopramide (10 mg/2 mL ampoule, Sina Darou Pharmaceutical Co., Iran) diluted with normal saline to a final volume of 5 mL will be administered intravenously over 30–60 seconds, 5 minutes before spinal anesthesia. The final volume, timing, injection rate, and all anesthesia-related conditions will be identical in both groups. Four milligrams of injectable ondansetron (4 mg/2 mL ampoule, Actoverco Pharmaceutical Co., Iran) diluted with normal saline to a final volume of 5 mL will be administered intravenously over 30–60 seconds, 5 minutes before spinal anesthesia. All injection conditions and anesthesia protocols will match those of the metoclopramide group. Incidence and frequency of nausea and vomiting following the intervention. Timepoint: 0–1 hour after intervention,1–2 hours after intervention,2–4 hours after intervention,4–6 hours after intervention. Method of measurement: The incidence of nausea and vomiting will be recorded as dichotomous variables (Yes/No). In addition, the frequency (number of episodes) of nausea and vomiting will be documented during the following postoperative time intervals:. Oroumia University of Medical Sciences Approved 2026-02-18 Research Ethics Committees of Urmia University of Medical Sciences Urmia University of Medical Sciences., Emergency Alley., Resalat Boulevard., Urmia Urmia West Azarbaijan Iran (Islamic Republic of)