The efficacy of aprepitant for the prevention of postoperative nausea and vomiting after bariatric surgery.
Phase 1
Recruiting
- Conditions
- Postoperative nausea and vomitingTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-508849-40-00
- Lead Sponsor
- niversity Of Tartu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
Patient is scheduled for bariatric surgery - LSG (laparoscopic sleeve gastrectomy),RYGB(Roux-en-Y) or OAGB(one-anastomosis MINI gastric bypass)., Patients are adult - 18 years or older., Patients have at least 2 risk factors for PONV - female sex, non-smokers, post-operative opioid analgesia, previous PONV and a duration of surgery longer than 1 hour., Obesity with a BMI more than 30.
Exclusion Criteria
Revision bariatric surgery., Known intolerance to the study drug - aprepitant.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Decrease the incidence of postoperative nausea and vomiting.;Secondary Objective: Decrease PONV severity, Decrease the use of rescue medications for PONV., Increase in patient satisfaction., Decrease the length of recovery room stay., Decrease in length of hospitalisation following bariatric surgery.;Primary end point(s): Incidence of PONV, Severity of PONV measured by NRS (numeric rate scale) and Rhodes scale, Use of rescue medication, type and dose.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Correlation between intraabdominal pressure during surgery and PONV incidence and severity.;Secondary end point(s):Length of stay in recovery room;Secondary end point(s):Length of hospital stay;Secondary end point(s):Subjective patient satisfaction assessment NRS (1-10) of postoperative period.