The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

Sponsor

Hospital General Tlahuac (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05772676

Collaborator

(none)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

100.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity Nausea and Vomiting, Postoperative	Drug: Aprepitant Other: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 vomitingA 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

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2022

Actual Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aprepitant Aprepitant (80 or 125 mg) + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg	Drug: Aprepitant 80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery
Placebo Comparator: Placebo Placebo + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg	Other: Placebo Placebo + standard antiemetic regimen, once two hours before surgery

Arm

Intervention/Treatment

Experimental: Aprepitant

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

Drug: Aprepitant

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

Placebo Comparator: Placebo

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

Other: Placebo

Placebo + standard antiemetic regimen, once two hours before surgery

Outcome Measures

Primary Outcome Measures

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 12 hrs (Rhodes index) [12 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.