The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

Hospital General Tlahuac400 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

400

Conditions

Obesity Nausea and Vomiting, Postoperative

Interventions

AprepitantDRUG

80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery

PlaceboOTHER

Placebo + standard antiemetic regimen, once two hours before surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital General Tlahuac

Mexico City, Mexico

Outcomes

Primary Outcomes

Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index)

Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhodes scale

Time frame: 0 postoperative hours

Patient's postoperative nausea and vomiting evaluation at 6 hrs (Rhodes index)

Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale

Time frame: 6 postoperative hours

Patient's postoperative nausea and vomiting evaluation at 12 hrs (Rhodes index)

Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale

Time frame: 12 postoperative hours

Patient's postoperative nausea and vomiting evaluation at 24 hrs (Rhodes index)

Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale

Time frame: 24 postoperative hours

Data from ClinicalTrials.gov

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