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

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.

Conditions

• Post-operative Nausea and Vomiting
• Laparoscopic Sleeve Gastrectomy

Interventions

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

Sponsors & Collaborators

• Stony Brook University

  lead OTHER

Principal Investigators

• Konstantinos Spaniolas, MD · Stony Brook University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-28

Primary Completion

2019-03-30

Completion

2019-04-01

FDA Drug

Yes

Countries

• United States

Study Locations