Dual-dose Aprepitant to Reduce Postoperative Nausea and Vomiting After Laparoscopic Bariatric Surgery.

NCT05189756 | Terminated Phase 4 DMC

• 1 other identifier: BECD-2-21
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative nausea and vomiting (PONV) is unpleasant and increases health care costs. Despite modern techniques and prophylaxis, PONV rates remain high after laparoscopic bariatric surgery. We aim to reduce PONV after laparoscopic bariatric surgery using aprepitant with a similar scheme used for emetogenic chemotherapy.

Conditions

Postoperative Nausea and Vomiting; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Cumulative rate of PONV 48 hours after surgery

  Primary outcome is cumulative rate of PONV (defined as emesis including vomiting and retching, severe nausea \[\>6/10 on a numeric rating scale (NRS)\] and use of rescue medication) at 48 hours after surgery.

  48 hours

Secondary Outcomes (10)

• Severity of nausea

  3, 24 and 48 hours after surgery

• Incidence of emesis

  3, 24 and 48 hours after surgery

• Use of rescue medication for PONV

  3, 24 and 48 hours after surgery

• Use of opioid analgesics

  3, 24 and 48 hours after surgery

• Use of non-opioid analgesics

  3, 24 and 48 hours after surgery

Other Outcomes (1)

• Adverse Events

  3, 24 and 48 hours after surgery, 30 days after surgery

Study Arms (2)

Verum

EXPERIMENTAL

Patients will receive 2 encapsulated capsules containing aprepitant 80mg to be ingested with a sip of water 2 hours before surgery and 24 hours after surgery. Surgery will follow our hospital enhanced recovery after surgery (ERAS) standard (general anaesthesia using volatile anaesthetics, intravenous dexamethasone 8mg and ondansetron 4mg for PONV prophylaxis).

Drug: Aprepitant 80 mg

Placebo

PLACEBO COMPARATOR

Patients will receive similar looking encapsulated capsules containing only placebo to be ingested with a sip of water 2 hours before surgery and 24 hours after surgery. Surgical and anaesthetic procedures are identical to the verum arm.

Drug: Placebo

Interventions

Aprepitant 80 mg DRUG

Encapsulated capsule of aprepitant 80mg to make it look alike to the placebo.

Also known as: Aprepitant Zentiva 80mg

Verum

Placebo DRUG

Encapsulated placebo capsules for optical, acoustical and haptic blinding.

Also known as: Placebo Capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and more
• Scheduled for an elective, laparoscopic bariatric surgery (either laparoscopic gastric sleeve resection or laparoscopic gastric bypass)
• BMI \> 30 kg/m2
• moderate to high risk for PONV (defined as APFEL score of 2 or higher)
• Informed Consent as documented by signature (see appendix 2).

You may not qualify if:

• emergency or open abdominal surgery;
• contraindication to aprepitant:
• known allergy/hypersensitivity
• on pimozide, terfenadine, astemizole or cisapride
• on regular medication with known interaction with the study drug:
• benzodiazepines
• ketoconazole, itraconazole
• rifampicin, clarithromycin
• paroxetine
• diltiazem
• carbamazepine, phenytoin
• tolbutamid
• ritonavir
• St. John's wort
• patients with history of chronic nausea/vomiting or taking medication with known antiemetic properties (dexamethasone, metoclopramide, meclozine)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christian M Beilstein, MD

  Bern University Hospital, University of Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Verum, placebo and block-randomisation will be provided by hospital pharmacy. Therefore, patients, treating team and researcher will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomised, placebo-controlled, triple-blind, single centre, two-arm parallel groups superiority trial assessing incidence of PONV 48 hours after laparoscopic bariatric surgery.

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 12, 2022
• Study Start: March 17, 2022
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)