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Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The investigators hypothesize that the intervention group will experience a reduction of nausea-related prolonged hospital stay and significantly improve patient-reported quality of recovery from surgery and quality of life.
To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs Nausea specific-intervention group. All subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life. The total sample size is 83. This study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy, which is currently poorly characterized. By allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Stony Brook University Hospital
Stony Brook, New York, United States
Start Date
August 28, 2017
Primary Completion Date
March 30, 2019
Completion Date
April 1, 2019
Last Updated
February 14, 2024
83
ACTUAL participants
Aprepitant 80 mg Oral Capsule
DRUG
scopolamine transdermal
DRUG
Total intravenous anesthesia
PROCEDURE
Dexamethasone
DRUG
Ondansetron
DRUG
Reglan
DRUG
Ondansetron
DRUG
Compazine
DRUG
Sugammadex
DRUG
Propofol
DRUG
dexmedetomidine
DRUG
Fentanyl
DRUG
Sevoflurane
DRUG
Desflurane
DRUG
Lead Sponsor
Stony Brook University
NCT06326983
NCT06515691
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