CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 83 enrolled
Drug / intervention
Aprepitant 80 mg Oral Capsule +13 moredrug
Likely dose
Aprepitant 80 mg Oral Capsulefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03435003
NCT03435003Phase 4Completed

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

Stony Brook University·interventional·Posted Feb 15, 2018·Updated Feb 14, 2024

In Brief

A Phase 4 clinical trial evaluating Aprepitant 80 mg Oral Capsule, scopolamine transdermal, and 11 other interventions for Post-operative Nausea and Vomiting and Laparoscopic Sleeve Gastrectomy. Completed, enrolled 83 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedFeb 15, 2018
Enrollment StartAug 28, 2017
Primary CompletionMar 30, 2019
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.4 years ago

Interventions

Aprepitant 80 mg Oral Capsuledrug

aprepitant 80 mg orally one hour prior to scheduled surgery

scopolamine transdermaldrug

scopolamine transdermal patch one hour prior to scheduled surgery

Total intravenous anesthesiaprocedure

Maintenance of anesthesia without the use of inhaled anesthetics.

Dexamethasonedrug

Dexamethasone 8 mg intraoperatively

Ondansetrondrug

Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.

Reglandrug

Postoperatively scheduled Reglan

Ondansetrondrug

Postoperatively scheduled ondansetron

Compazinedrug

Postoperatively as needed compazine for breakthrough PONV

Sugammadexdrug

Reversal with sugammadex

Propofoldrug

Intravenous anesthesia will be maintained through IV propofol

dexmedetomidinedrug

maintenance of anesthesia in the intervention arm

Fentanyldrug

intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance

Sevofluranedrug

inhalational anesthesia

Desfluranedrug

inhalational anesthesia