Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery
NCT ID: NCT06488001
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
132 participants
INTERVENTIONAL
2022-08-26
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo
This arm receives the placebo drug. This medication is taken the night before, 2 hours before surgery, and the night after surgery.
Placebo
Placebo given the night before surgery, 2 hours prior to surgery, and the evening after surgery.
Active
This arm receives the pantoprazole 40mg tablet. This medication is taken the night before, 2 hours before surgery, and the night after surgery.
pantoprazole
Pantoprazole 40mg given the night before surgery, 2 hours prior to surgery, and the evening after surgery.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
79 Years
FEMALE
Yes
Sponsors
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United States Naval Medical Center, Portsmouth
FED
Responsible Party
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Principal Investigators
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Casey Timmerman, DO
Role: PRINCIPAL_INVESTIGATOR
United States Naval Medical Center, Portsmouth
Locations
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Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NMCP.2021.0131
Identifier Type: -
Identifier Source: org_study_id
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