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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-79
SponsorUnited States Naval Medical Center, Portsmouth

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • pantoprazole

    Drug

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

  • Placebo

    Drug

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

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ActiveActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Nausea and Vomiting

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.

Time frame
From enrollment until their postoperative visit at 6 weeks

Secondary outcomes

1

Time to Oral Intake

Measure the time from surgery until patients can tolerate oral intake.

Time frame
From surgery until first meal, usually within a few hours.

Other outcomes

Sponsors and contacts

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