Recruiting
Phase 2

Pantoprazole

Sponsor:

United States Naval Medical Center, Portsmouth

Code:

NCT06488001

Conditions

Postoperative Nausea and Vomiting

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

pantoprazole

Placebo

Study Details

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 of 18 and 79.

Researchers will compare a placebo to the active medication.

Participants will be asked to take three pills around their surgery, two taken before and one taken the night after.

Conditions

Postoperative Nausea and Vomiting

Study ID

NCT06488001

Start date

Aug 26, 2022

Status verified date

May, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

This arm receives the placebo drug. This medication is taken the night before, 2 hours before surgery, and the night after surgery.

active comparator: Active

This arm receives the pantoprazole 40mg tablet. This medication is taken the night before, 2 hours before surgery, and the night after surgery.

Interventions

pantoprazole

Pantoprazole 40mg given the night before surgery, 2 hours prior to surgery, and the evening after surgery.

Placebo

Placebo given the night before surgery, 2 hours prior to surgery, and the evening after surgery.

Primary outcome measure

  • Postoperative Nausea and Vomiting [ Time Frame: From enrollment until their postoperative visit at 6 weeks ]

Central Contacts and Locations

Central contacts

Casey Timmerman, DO

757-953-7767casey.j.timmerman2.mil@health.mil

Melissa Infosino, MD

Melissa.R.Infosino.mil@health.mil

Locations

Naval Medical Center Portsmouth

Recruiting

Portsmouth, Virginia, United States, 23708

Contacts

Casey Timmerman, DO

757-953-7767casey.j.timmerman2.mil@health.mil

Principal Investigator:

Casey Timmerman, DO

More Information

Sponsor

United States Naval Medical Center, Portsmouth

Last update posted

May 21, 2025

Last verified

May, 2025

Keywords

  • PONV
  • Postoperative nausea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, Portsmouth on 2025-05-21.