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

NCT03435003 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1074296-3
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bariatric Procedure

Outcome Measures

Primary Outcomes (1)

• Number of Participants With PONV-related Delay of Hospital Discharge

  The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.

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

Secondary Outcomes (5)

• Severity of PONV Measured Using a 10-point Verbal Rating Scale.

  Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks

• Severity of PONV Measured Using the Rhodes Index

  Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks

• Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey

  24 hours and 3 weeks

• GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey

  Baseline, 24 hours and 3 weeks

• Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument

  Baseline, 24 hours and 3 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch. B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation. C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.

Drug: Aprepitant 80 mg Oral Capsule; Drug: scopolamine transdermal; Procedure: Total intravenous anesthesia; Drug: Dexamethasone; Drug: Ondansetron; Drug: Reglan; Drug: Compazine; Drug: Sugammadex; Drug: Propofol; Drug: dexmedetomidine; Drug: Fentanyl

Control Arm

ACTIVE COMPARATOR

A) Pre-operatively: No intervention B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg. C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.

Drug: Dexamethasone; Drug: Ondansetron; Drug: Reglan; Drug: Compazine; Drug: Sugammadex; Drug: Sevoflurane; Drug: Desflurane

Interventions

Aprepitant 80 mg Oral Capsule DRUG

aprepitant 80 mg orally one hour prior to scheduled surgery

Also known as: Emend

Intervention Arm

scopolamine transdermal DRUG

scopolamine transdermal patch one hour prior to scheduled surgery

Also known as: Transderm Scop

Intervention Arm

Total intravenous anesthesia PROCEDURE

Maintenance of anesthesia without the use of inhaled anesthetics.

Intervention Arm

Dexamethasone DRUG

Dexamethasone 8 mg intraoperatively

Control Arm; Intervention Arm

Ondansetron DRUG

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

Also known as: Zofran

Control Arm; Intervention Arm

Reglan DRUG

Postoperatively scheduled Reglan

Also known as: Metoclopramide

Control Arm; Intervention Arm

Compazine DRUG

Postoperatively as needed compazine for breakthrough PONV

Also known as: Compro

Control Arm; Intervention Arm

Sugammadex DRUG

Reversal with sugammadex

Also known as: Bridion

Control Arm; Intervention Arm

Propofol DRUG

Intravenous anesthesia will be maintained through IV propofol

Also known as: Diprivan

Intervention Arm

dexmedetomidine DRUG

maintenance of anesthesia in the intervention arm

Also known as: Precedex

Intervention Arm

Fentanyl DRUG

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

Intervention Arm

Sevoflurane DRUG

inhalational anesthesia

Also known as: Ultane

Control Arm

Desflurane DRUG

inhalational anesthesia

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years and older) undergoing LSG

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794-8191, United States

Location

Related Publications (1)

• Naeem Z, Nie L, Drakos P, Yang J, Gan TJ, Pryor AD, Spaniolas K. The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2021 Aug;25(8):2107-2109. doi: 10.1007/s11605-021-04923-4. Epub 2021 Feb 2. No abstract available.

  PMID: 33528788 DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

Aprepitant; Scopolamine; Dexamethasone; Ondansetron; Metoclopramide; Prochlorperazine; Sugammadex; Propofol; Dexmedetomidine; Fentanyl; Sevoflurane; Desflurane

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Phenothiazines; Sulfur Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Piperidines; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Ethyl Ethers

Results Point of Contact

• Title: Dr. Konstantinos Spaniolas
• Organization: Stony Brook University

konstantinos.spaniolas@stonybrookmedicine.edu

631-444-8330

Study Officials

• Konstantinos Spaniolas, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery, School of Medicine Bariatric, Foregut and Advanced GI Surgery

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: February 15, 2018
• Study Start: August 28, 2017
• Primary Completion: March 30, 2019
• Study Completion: April 1, 2019
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-02

Locations

US (1)