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

NCT06488001 | Recruiting Phase 2 FDA Drug

• 1 other identifier: NMCP.2021.0131
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Keywords

PONV; Postoperative nausea

Outcome Measures

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.

  From enrollment until their postoperative visit at 6 weeks

Secondary Outcomes (1)

• Time to Oral Intake

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Active

ACTIVE COMPARATOR

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

Interventions

pantoprazole DRUG

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

Also known as: proton pump inhibitor

Active

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

RECRUITING

Related Publications (14)

• Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088.

  PMID: 9717590 BACKGROUND

• Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.

  PMID: 19434647 BACKGROUND

• Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.

  PMID: 10757584 BACKGROUND

• Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. doi: 10.1034/j.1399-6576.2002.460801.x.

  PMID: 12190791 BACKGROUND

• Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.

  PMID: 984016 BACKGROUND

• Kwon YS, Choi JW, Lee HS, Kim JH, Kim Y, Lee JJ. Effect of a Preoperative Proton Pump Inhibitor and Gastroesophageal Reflux Disease on Postoperative Nausea and Vomiting. J Clin Med. 2020 Mar 18;9(3):825. doi: 10.3390/jcm9030825.

  PMID: 32197451 BACKGROUND

• Koivuranta M, Laara E, Snare L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia. 1997 May;52(5):443-9. doi: 10.1111/j.1365-2044.1997.117-az0113.x.

  PMID: 9165963 BACKGROUND

• Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.

  PMID: 23035051 BACKGROUND

• Apfel CC, Turan A, Souza K, Pergolizzi J, Hornuss C. Intravenous acetaminophen reduces postoperative nausea and vomiting: a systematic review and meta-analysis. Pain. 2013 May;154(5):677-689. doi: 10.1016/j.pain.2012.12.025. Epub 2013 Jan 11.

  PMID: 23433945 BACKGROUND

• Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002 Feb;88(2):234-40. doi: 10.1093/bja/88.2.234.

  PMID: 11883387 BACKGROUND

• Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.

  PMID: 32467512 BACKGROUND

• Carlisle JB, Stevenson CA. Drugs for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD004125. doi: 10.1002/14651858.CD004125.pub2.

  PMID: 16856030 BACKGROUND

• Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006.

  PMID: 27521884 BACKGROUND

• Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.

  PMID: 10475299 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Pantoprazole; Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Casey Timmerman, DO

  United States Naval Medical Center, Portsmouth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey Timmerman, DO

CONTACT

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

Melissa Infosino, MD

CONTACT

Melissa.R.Infosino.mil@health.mil

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: August 26, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)