Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery

May 16, 2025 updated by: United States Naval Medical Center, Portsmouth

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 gelatin capsules will be prepared in advance containing either placebo or 40 mg of Pantoprazole, each medication packet will have three capsules of either active drug or placebo. The patient and all study members will be blinded. Participants will be instructed when to take their specific medication (PPI or placebo) prior to surgery along with their other ERAS protocol instructions.

Study Medication/Placebo Administration Subjects will take either oral Pantoprazole 40 mg or placebo the evening prior to surgery, 2 hours prior to scheduled surgery (time to peak bioavailability is 2.5 hrs in adults) and 12 hours following surgery completion. The final dose is to provide additional effect given that PONV can continue up to 24 hours following surgery. All surgeries at this facility utilize an ERAS protocol includes the perioperative use of Zofran 4 mg and Decadron 4 mg for all patients; this practice will continue unchanged for participating patients.

Data Collection/Post-Operative Patient Satisfaction Evaluation Subjects will be evaluated postoperatively with a visual analog scale (VAS) to determine incidence and severity of PONV; this has been used similarly in prior studies. A score of 0 indicates no nausea and higher scores reflect progressively greater severity. Assessment with VAS will be conducted two hours after and the morning following surgery completion; scores will be compared between groups. The VAS will be administered in person by study personnel while patients remain in hospital. Study personnel will administer the VAS by phone for patients who have been discharged by the morning following surgery. Time to first meal (PO) will also be measured and compared as will the use of rescue antiemetics to treat nausea postoperatively. Patients will also have a postoperative telehealth visit one week following their operation to review patient satisfaction and rate their experience using the Treatment Acceptability and Preference (TRAP) Questionnaire. This is a validated standard questionnaire that will be verbally administered by study personnel and used to assess patient satisfaction with their perioperative treatment specific to PONV [14]. All data will be collected and stored on password protected excel spreadsheets or in a locked secure environment in the Women's Health Clinic. Subject ID log will be kept separate from data collection tool to maintain blinding by a study team member. Essentris records will be reviewed by the study team member to specifically evaluate time to first meal, reported vomiting and any rescue antiemetic use. All data collected to include VAS and TRAP scores will be collected and stored on password protected excel spreadsheets. Subject ID log will be kept separate from data collection tool to maintain blinding. Analysis will be conducted on appropriate statistical software. To confirm accurate data entry from Essentris, 10% of patient records will be randomly reviewed by a second study investigator (other than the original study team member) and compared prior to data analysis. If any discrepancies are identified in this process, Essentris data will then be reviewed again for all study participants. A list of all discrepancies will be maintained and adjudicated by a third investigator to verify accuracy.

Incidental Malignancy If an unexpected malignancy is found during the surgical procedure, the subject will be withdrawn from the study and all data collected prior to surgery will be discarded.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Recruiting
        • Naval Medical Center Portsmouth
        • Contact:
        • Principal Investigator:
          • Casey Timmerman, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Placebo
Placebo given the night before surgery, 2 hours prior to surgery, and the evening 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.
Drug: pantoprazole
Pantoprazole 40mg given the night before surgery, 2 hours prior to surgery, and the evening after surgery.
Other Names:
  • proton pump inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Nausea and Vomiting
Time Frame: From enrollment until their postoperative visit at 6 weeks
Postoperative nausea and vomiting compared between two groups using Visual Analog Scale from 0-10. A score of 0 indicates no nausea and higher scores reflect progressively greater severity.
From enrollment until their postoperative visit at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Oral Intake
Time Frame: From surgery until first meal, usually within a few hours.
Measure the time from surgery until patients can tolerate oral intake.
From surgery until first meal, usually within a few hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, Portsmouth

Investigators

  • Principal Investigator: Casey Timmerman, DO, United States Naval Medical Center, Portsmouth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCP.2021.0131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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