Clinical trial

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

Name

1074296-3

Description

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.

Trial arms

Trial start

2017-08-28

Estimated PCD

2019-03-30

Trial end

2019-04-01

Status

Completed

Phase

Early phase I

Treatment

Aprepitant 80 mg Oral Capsule

aprepitant 80 mg orally one hour prior to scheduled surgery

Arms:

Intervention Arm

Other names:

Emend

scopolamine transdermal

scopolamine transdermal patch one hour prior to scheduled surgery

Arms:

Intervention Arm

Other names:

Transderm Scop

Total intravenous anesthesia

Maintenance of anesthesia without the use of inhaled anesthetics.

Arms:

Intervention Arm

Dexamethasone

Dexamethasone 8 mg intraoperatively

Arms:

Control Arm, Intervention Arm

Ondansetron

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

Arms:

Control Arm, Intervention Arm

Other names:

Zofran

Reglan

Postoperatively scheduled Reglan

Arms:

Control Arm, Intervention Arm

Other names:

Metoclopramide

Ondansetron

Postoperatively scheduled ondansetron

Arms:

Control Arm, Intervention Arm

Other names:

Zofran

Compazine

Postoperatively as needed compazine for breakthrough PONV

Arms:

Control Arm, Intervention Arm

Other names:

Compro

Sugammadex

Reversal with sugammadex

Arms:

Control Arm, Intervention Arm

Other names:

Bridion

Propofol

Intravenous anesthesia will be maintained through IV propofol

Arms:

Intervention Arm

Other names:

Diprivan

dexmedetomidine

maintenance of anesthesia in the intervention arm

Arms:

Intervention Arm

Other names:

Precedex

Fentanyl

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

Arms:

Intervention Arm

Sevoflurane

inhalational anesthesia

Arms:

Control Arm

Other names:

Ultane

Desflurane

inhalational anesthesia

Arms:

Control Arm

Size

Primary endpoint

Number of Participants With PONV-related Delay of Hospital Discharge

up to 1 week post-operation (up to 2 weeks from baseline)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 83, 'type': 'ACTUAL'}}

Updated at

2024-02-14

1 organization

12 products

2 indications

Organization

Stony Brook University

Product

Aprepitant

Indication

Post-operative Nausea and Vomiting

Indication