NCT05772676

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4 obesity

Timeline
Completed

Started Dec 2022

Shorter than P25 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

February 9, 2023

Last Update Submit

March 6, 2023

Conditions

ObesityNausea and Vomiting, Postoperative

Keywords

Laparoscopic Gastric SleeveBariatric SurgeryNausea and Vomiting, PostoperativeAprepitant

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Aprepitant

EXPERIMENTAL

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

Drug: Aprepitant

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

AprepitantDRUG

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

Aprepitant
PlaceboOTHER

Placebo + standard antiemetic regimen, once two hours before surgery

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years old.
  • Non-smokers.
  • Obesity with BMI \> 30 kg/m2.
  • Undergoing laparoscopic gastric sleeve.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Tlahuac

Mexico City, Mexico

Location

MeSH Terms

Conditions

ObesityPostoperative Nausea and Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Triple-blinded, 1:1ratio to Aprepitant or placebo
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, UNAM

Study Record Dates

First Submitted

February 9, 2023

First Posted

March 16, 2023

Study Start

December 1, 2022

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)