The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

Phase 4

Active, not recruiting

• Conditions: Obesity; Nausea and Vomiting, Postoperative
• Interventions: Other: Placebo; Drug: Aprepitant

• Registration Number: NCT05772676
• Lead Sponsor: Hospital General Tlahuac

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-01-01
• Study First Submitted: 2023-02-09
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg
Aprepitant	Aprepitant	Aprepitant (80 or 125 mg) + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg

Primary Outcome Measures

Name	Time	Method
Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index)	0 postoperative hours	Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhodes scale
Patient's postoperative nausea and vomiting evaluation at 6 hrs (Rhodes index)	6 postoperative hours	Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Patient's postoperative nausea and vomiting evaluation at 24 hrs (Rhodes index)	24 postoperative hours	Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Patient's postoperative nausea and vomiting evaluation at 12 hrs (Rhodes index)	12 postoperative hours	Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale

Trial Locations

Locations (1)

Hospital General Tlahuac; 🇲🇽 Mexico City, Mexico