The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

Obesity Clinical Trial

Official title:

The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastric Sleeve Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05772676
• Other study ID #: APREPITANTBAJAMED-01-2023
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2023
• Source: Hospital General Tlahuac
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Postoperative
• Obesity
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant
80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery

Other:
• Placebo
Placebo + standard antiemetic regimen, once two hours before surgery

Locations

Country	Name	City	State
Mexico	Hospital General Tlahuac	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Tlahuac

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0 postoperative hours
Primary	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	6 postoperative hours
Primary	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	12 postoperative hours
Primary	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	24 postoperative hours