Status:
RECRUITING
Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery
Lead Sponsor:
United States Naval Medical Center, Portsmouth
Conditions:
Postoperative Nausea and Vomiting
Eligibility:
FEMALE
18-79 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to see if pantoprazole (a proton pump inhibitor used for acid reflux/heart burn) can reduce nausea and vomiting after gynecologic surgery in women between the ages o...
Detailed Description
Randomization Recruited subjects will be randomly assigned a study number and be provided a numerically matching medication packet prepared in advance by pharmacy support staff. Identical opaque gelat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06488001
Start Date
August 26 2022
End Date
December 1 2026
Last Update
May 21 2025
Active Locations (1)
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1
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708