The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-04-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Obesity Nausea and Vomiting, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled clinical trial conducted in obese patients undergoing laparoscopic gastric sleeve surgery to assess the efficacy of Aprepitant (80 or 125 mg) in combination with a standard antiemetic regimen (Ondansetron + Metoclopramide + Dexamethasone) is presented vs placebo + the same standard regimen, evaluating postoperative nausea and vomiting by means of a specific scale (Rhodes index) for the assessment of nausea and vomiting

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Triple-blinded, 1:1ratio to Aprepitant or placebo

Study Groups

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Aprepitant

Aprepitant (80 or 125 mg) + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg

Group Type EXPERIMENTAL

Aprepitant

Intervention Type DRUG

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

Placebo

Placebo + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo + standard antiemetic regimen, once two hours before surgery

Interventions

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Aprepitant

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

Intervention Type DRUG

Placebo

Placebo + standard antiemetic regimen, once two hours before surgery

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No