Clinical trial NCT06488001: Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery
Official title: Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Keywords: PONV
Postoperative nausea
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2024-07-05
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Nausea and Vomiting
timeFrame: From enrollment until their postoperative visit at 6 weeks
Secondary outcomes:
measure: Time to Oral Intake
timeFrame: From surgery until first meal, usually within a few hours.
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: United States Naval Medical Center, Portsmouth
name: Casey Timmerman, DO
role: PRINCIPAL_INVESTIGATOR
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