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The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

Primary Purpose

Obesity, Nausea and Vomiting, Postoperative

Status
Active
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Aprepitant
Placebo
Sponsored by
Hospital General Tlahuac
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Laparoscopic Gastric Sleeve, Bariatric Surgery, Nausea and Vomiting, Postoperative, Aprepitant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital General Tlahuac

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aprepitant

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
February 9, 2023
Last Updated
March 6, 2023
Sponsor
Hospital General Tlahuac
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1. Study Identification

Unique Protocol Identification Number
NCT05772676
Brief Title
The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting
Official Title
The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastric Sleeve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Tlahuac

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Nausea and Vomiting, Postoperative
Keywords
Laparoscopic Gastric Sleeve, Bariatric Surgery, Nausea and Vomiting, Postoperative, Aprepitant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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 vomiting
Masking
ParticipantCare ProviderInvestigator
Masking Description
Triple-blinded, 1:1ratio to Aprepitant or placebo
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aprepitant
Arm Type
Experimental
Arm Description
Aprepitant (80 or 125 mg) + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Intervention Description
80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo + standard antiemetic regimen, once two hours before surgery
Primary Outcome Measure Information:
Title
Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index)
Description
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhodes scale
Time Frame
0 postoperative hours
Title
Patient's postoperative nausea and vomiting evaluation at 6 hrs (Rhodes index)
Description
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Time Frame
6 postoperative hours
Title
Patient's postoperative nausea and vomiting evaluation at 12 hrs (Rhodes index)
Description
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Time Frame
12 postoperative hours
Title
Patient's postoperative nausea and vomiting evaluation at 24 hrs (Rhodes index)
Description
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Time Frame
24 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital General Tlahuac
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

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