Comparing two combinations of medications to prevent nausea after cesarean sections
Comparison Between Intravenous Ondanosteron and Metclopromide Versus Ondanesteron and Dexamethasone Effects on the Prevention of Postoperative Nausea and Vomiting in Cesarean Section
This study is testing two different combinations of nausea medications to see which one works better for women after having a cesarean section.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Suez Canal University Academic / other |
| Locations | 2 sites (Ismailia and 1 other locations) |
| Trial ID | NCT06810531 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different combinations of antiemetic medications in preventing intraoperative nausea and vomiting (IONV) and postoperative nausea and vomiting (PONV) in patients undergoing cesarean sections. Participants will be randomly assigned to receive either ondansetron combined with dexamethasone or ondansetron combined with metoclopramide. The primary objective is to compare the incidence of PONV in the first 24 hours post-surgery. The study addresses a common issue faced by many women during cesarean deliveries, aiming to improve patient satisfaction and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are ASA II and III pregnant patients aged 18-40 scheduled for elective cesarean sections under spinal anesthesia.
Not a fit: Patients with ASA physical status greater than III, those with a BMI over 35, or those with a history of motion sickness or allergies to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of nausea and vomiting in women undergoing cesarean sections, enhancing their recovery experience.
How similar studies have performed: Previous studies have shown the effectiveness of ondansetron in preventing nausea and vomiting, but this specific comparison of combinations is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ASA II and III pregnant patients scheduled for elective C.S under spinal anesthesia 2. Age 18-40 years 3. Fasting before the procedure for 8 hours from solid food intake and 2 hours from water intake Exclusion Criteria: 1. Patients with ASA physical status \> III. 2. BMI \>35. 3. History of motion sickness and extrapyramidal disease. 4. Smokers. 5. History of allergy to any of involved drugs in the study. 6. Patients developed nausea and vomiting and/or received antiemetic drugs within 24 hours prior to surgery. 7. History of hyperemesis gravidarum. 8. History of peptic ulcer disease.
Where this trial is running
Ismailia and 1 other locations
- Aiman Al-Touny — Ismailia, Egypt (Not_yet_recruiting)
- Suez Canal University Hospital — Ismailia, Egypt (Recruiting)
Study contacts
- Principal investigator: Aiman Al-Touny, MD — Suez Canal University
- Study coordinator: Aiman Al-Touny, MD
- Email: aimantouny@yahoo.com
- Phone: +201008185785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.