Using Pantoprazole to Prevent Nausea After Gynecologic Surgery
Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery
This study is testing if giving pantoprazole can help women avoid nausea and vomiting after gynecologic surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | Female |
| Sponsor | United States Naval Medical Center, Portsmouth Federal |
| Locations | 1 site (Portsmouth, Virginia) |
| Trial ID | NCT06488001 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of pantoprazole, a proton pump inhibitor, in reducing postoperative nausea and vomiting (PONV) in women undergoing elective gynecologic surgery. Participants will be randomly assigned to receive either pantoprazole or a placebo, with medication administered before and after surgery. The study will utilize a double-blind design to ensure unbiased results, and postoperative nausea will be assessed using a visual analog scale. The trial is part of an enhanced recovery after surgery (ERAS) protocol that includes standard anti-nausea medications.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 79 undergoing elective gynecologic surgery under general anesthesia.
Not a fit: Patients who are pregnant, have gastrointestinal diseases requiring ongoing management, or have a history of severe PONV may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative nausea and vomiting, improving recovery experiences for patients.
How similar studies have performed: Previous studies have shown varying degrees of success with similar approaches, but this specific use of pantoprazole for PONV prevention is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergoing elective gynecological surgery by either an open abdominal or minimally invasive approach (to include both endoscopic and vaginal). Procedure must be performed under general anesthesia. Exclusion Criteria: * Pregnant, * Patients with gastrointestinal disease requiring ongoing medical management. * Prior gastrointestinal surgery with the exception of diagnostic procedures, appendectomy and cholecystectomy. * Patients with a history of H2 receptor blocker use, proton pump inhibitor use or other GERD specific therapy within 30 days of surgery. * Any patient identified by their surgical care team as having a history of PONV warranting additional perioperative prophylaxis. * Known r suspected malignancy * Lactose intolerance
Where this trial is running
Portsmouth, Virginia
- Naval Medical Center Portsmouth — Portsmouth, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Casey Timmerman, DO — United States Naval Medical Center, Portsmouth
- Study coordinator: Casey Timmerman, DO
- Email: casey.j.timmerman2.mil@health.mil
- Phone: 757-953-7767
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.