The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

Hospital General Tlahuac

Status and phase

Active, not recruiting

Phase 4

Conditions

Obesity

Nausea and Vomiting, Postoperative

Treatments

Drug: Aprepitant

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05772676

APREPITANTBAJAMED-01-2023

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen

Full description

After being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to Aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery).

The standard antiemetic regimen will be Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg

Enrollment

400 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 to 65 years old.
Non-smokers.
Obesity with BMI > 30 kg/m2.
Undergoing laparoscopic gastric sleeve.

Exclusion criteria

Documented hypersensitivity to any component of the study regimen.
Current treatment with: Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole) or Propulsid (cisapride).
Allergy to opioid drugs used in the anesthetic protocol.
Drug or alcohol abuse.
Chronic nausea and vomiting.
Previous bariatric procedures.