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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
83
aprepitant 80 mg orally one hour prior to scheduled surgery
scopolamine transdermal patch one hour prior to scheduled surgery
Maintenance of anesthesia without the use of inhaled anesthetics.
Dexamethasone 8 mg intraoperatively
Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
Postoperatively scheduled Reglan
Postoperatively scheduled ondansetron
Postoperatively as needed compazine for breakthrough PONV
Reversal with sugammadex
Intravenous anesthesia will be maintained through IV propofol
maintenance of anesthesia in the intervention arm
intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
inhalational anesthesia
inhalational anesthesia
Stony Brook University Hospital
Stony Brook, New York, United States
Number of Participants With PONV-related Delay of Hospital Discharge
The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.
Time frame: up to 1 week post-operation (up to 2 weeks from baseline)
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
The severity of PONV will be measured using a visual analogue scale. \[0-10\] The higher the value, the worse the outcome.
Time frame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Severity of PONV Measured Using the Rhodes Index
The Rhodes Index of Nausea, Vomiting, and Retching (R-INVR) is a validated instrument used to measure the severity of Post-Operative Nausea and Vomiting (PONV). The index comprises eight items, each scored on a scale of 0 to 4, allowing for a total score range of 0 to 32 points . The scoring of each item on the Rhodes Index is as follows: 0 points represent a minimum level of disturbance, 4 points represent a maximum level of disturbance . The total score from these eight items is summed to represent the severity of PONV, with higher scores indicating worse PONV experience. The index encompasses three subscales named "experience," "occurrence," and "distress" . Each of these subscales contributes to the total score to provide a comprehensive measure of PONV severity. Any score above zero on the R-INVR indicates that the participant experienced nausea .
Time frame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey
The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. The higher the score, the worse the outcome.
Time frame: 24 hours and 3 weeks
GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey
The GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and sub-scores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.
Time frame: Baseline, 24 hours and 3 weeks
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
EQ-5D Descriptive System: Dimensions: Includes five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Levels: Each dimension has 5 severity levels: 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. Extreme problems Time Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks.
Time frame: Baseline, 24 hours and 3 weeks
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