Nausea and Vomiting, Postoperative, Obesity
Conditions
Keywords
Laparoscopic Gastric Sleeve, Bariatric Surgery, Nausea and Vomiting, Postoperative, Aprepitant
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
Interventions
DRUGAprepitant
80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery
OTHERPlacebo
Placebo + standard antiemetic regimen, once two hours before surgery
Sponsors
Hospital General Tlahuac
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Triple-blinded, 1:1ratio to Aprepitant or placebo
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 vomiting
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed