drugset / Trial / NCT03435003

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

NCT03435003

Phase 4 Completed 83 enrolled Stony Brook University
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2017-08-28
Primary completion
2019-03-30
Completion
2019-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprepitant Other / unclassified 80 mg Oral
Subject Scopolamine Unknown Topical
Comparator Desflurane Other / unclassified Inhaled
Background Dexamethasone Small molecule 8 mg Intravenous
Background Dexmedetomidine Other / unclassified
Background Fentanyl Other / unclassified
Background Metoclopramide Small molecule
Background Ondansetron Other / unclassified 4 mg Intravenous
Background Prochlorperazine Small molecule
Background Propofol Small molecule Intravenous
Comparator Sevoflurane Other / unclassified Inhaled
Background Sugammadex Other / unclassified 2 mg/kg Intravenous
Background Sugammadex Other / unclassified 4 mg/kg Intravenous

Indications

No indication recorded.