Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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 82. 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.

Official Title
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Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy

Conditions
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Post-operative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy

Intervention / Treatment
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* Drug: Aprepitant 80Mg Oral Capsule
* Drug: scopolamine transdermal
* Procedure: Total intravenous anesthesia
* Drug: Dexamethasone
* Drug: Ondansetron
* Drug: Reglan
* Drug: Ondansetron
* Drug: Compazine
* Drug: Sugammadex
* Drug: Propofol
* Drug: dexmedetomidine
* Drug: Fentanyl
* Drug: Sevoflurane
* Drug: Desflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (18 years and older) undergoing LSG Exclusion Criteria: Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents) Inability to provide informed consent History of chronic nausea and emesis requiring medication Poorly controlled diabetes (HgA1c>9 mg/dl), History of previous bariatric or gastro-esophageal surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch. B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation. C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication. | Drug: Aprepitant 80Mg Oral Capsule<br>* aprepitant 80 mg orally one hour prior to scheduled surgery<br>* Other names: Emend;Drug: scopolamine transdermal<br>* scopolamine transdermal patch one hour prior to scheduled surgery<br>* Other names: Transderm Scop;Procedure: Total intravenous anesthesia<br>* Maintenance of anesthesia without the use of inhaled anesthetics.<br>Drug: Dexamethasone<br>* Dexamethasone 8 mg intraoperatively<br>Drug: Ondansetron<br>* Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.<br>* Other names: Zofran;Drug: Reglan<br>* Postoperatively scheduled Reglan<br>* Other names: Metoclopramide;Drug: Ondansetron<br>* Postoperatively scheduled ondansetron<br>* Other names: Zofran;Drug: Compazine<br>* Postoperatively as needed compazine for breakthrough PONV<br>* Other names: Compro;Drug: Sugammadex<br>* Reversal with sugammadex<br>* Other names: Bridion;Drug: Propofol<br>* Intravenous anesthesuia will be maintained through IV propofol<br>* Other names: Diprivan;Drug: dexmedetomidine<br>* maintainance of anesthesia in the intervention arm<br>* Other names: Precedex;Drug: Fentanyl<br>* intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance<br>|
| Active Comparator: Control Arm<br>A) Pre-operatively: No intervention B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg. C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication. | Drug: Dexamethasone<br>* Dexamethasone 8 mg intraoperatively<br>Drug: Ondansetron<br>* Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.<br>* Other names: Zofran;Drug: Reglan<br>* Postoperatively scheduled Reglan<br>* Other names: Metoclopramide;Drug: Ondansetron<br>* Postoperatively scheduled ondansetron<br>* Other names: Zofran;Drug: Compazine<br>* Postoperatively as needed compazine for breakthrough PONV<br>* Other names: Compro;Drug: Sugammadex<br>* Reversal with sugammadex<br>* Other names: Bridion;Drug: Sevoflurane<br>* inhalational anesthesia<br>* Other names: Ultane;Drug: Desflurane<br>* inhalational anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of 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. | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of PONV measured using a visual analogue scale | The severity of PONV will be measured using a visual analogue scale. | Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks | 
| Severity of PONV measured using the Rhodes Index | The severity of PONV will be measured using the Rhodes Index. | Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks | 
| Quality of recovery measured using the QoR-15 survey | The quality of recovery from laparoscopic sleeve gastrectomy will be measured using the QoR-15 survey | 24 hours and 3 weeks | 
| GI specific quality of life using the GIQLI survey | Patients will be assessed for any perioperative changed in their quality of life using the GIQLI survey. | Baseline, 24 hours and 3 weeks | 
| Overall quality of life using the EQ-5D instrument | Patients will be assessed for any perioperative changed in their quality of life using the EQ-5D instrument. | Baseline, 24 hours and 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric Procedure