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

Last updated: November 13, 2024
Sponsor: United States Naval Medical Center, Portsmouth
Overall Status: Active - Recruiting

Phase

2

Condition

Colic

Stomach Discomfort

Lactose Intolerance

Treatment

Placebo

pantoprazole

Clinical Study ID

NCT06488001
NMCP.2021.0131
  • Ages 18-79
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Undergoing elective gynecological surgery by either an open abdominal or minimallyinvasive approach (to include both endoscopic and vaginal). Procedure must beperformed under general anesthesia.

Exclusion

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 orother GERD specific therapy within 30 days of surgery.

  • Any patient identified by their surgical care team as having a history of PONVwarranting additional perioperative prophylaxis.

  • Known r suspected malignancy

  • Lactose intolerance

Study Design

Total Participants: 132
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 26, 2022
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Naval Medical Center Portsmouth

    Portsmouth, Virginia 23708
    United States

    Active - Recruiting

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