NCT03435003

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Post-operative Nausea and Vomiting
• Laparoscopic Sleeve Gastrectomy

Interventions

Type	Name	Description
DRUG	Aprepitant 80 mg Oral Capsule	aprepitant 80 mg orally one hour prior to scheduled surgery
DRUG	scopolamine transdermal	scopolamine transdermal patch one hour prior to scheduled surgery
PROCEDURE	Total intravenous anesthesia	Maintenance of anesthesia without the use of inhaled anesthetics.
DRUG	Dexamethasone	Dexamethasone 8 mg intraoperatively
DRUG	Ondansetron	Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
DRUG	Reglan	Postoperatively scheduled Reglan
DRUG	Ondansetron	Postoperatively scheduled ondansetron
DRUG	Compazine	Postoperatively as needed compazine for breakthrough PONV
DRUG	Sugammadex	Reversal with sugammadex
DRUG	Propofol	Intravenous anesthesia will be maintained through IV propofol
DRUG	dexmedetomidine	maintenance of anesthesia in the intervention arm
DRUG	Fentanyl	intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
DRUG	Sevoflurane	inhalational anesthesia
DRUG	Desflurane	inhalational anesthesia

Timeline

• Start date: 2017-08-28
• Primary completion: 2019-03-30
• Completion: 2019-04-01
• First posted: 2018-02-15
• Last updated: 2024-02-14
• Results posted: 2024-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study