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

February 12, 2024 updated by: Konstantinos Spaniolas, Stony Brook University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs Nausea specific-intervention group. All subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life.

The total sample size is 83. This study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy, which is currently poorly characterized. By allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794-8191
        • Stony Brook University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm

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: scopolamine transdermal
scopolamine transdermal patch one hour prior to scheduled surgery
Other Names:
  • Transderm Scop
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.
Other Names:
  • Zofran
Drug: Reglan
Postoperatively scheduled Reglan
Other Names:
  • Metoclopramide
Drug: Ondansetron
Postoperatively scheduled ondansetron
Other Names:
  • Zofran
Drug: Compazine
Postoperatively as needed compazine for breakthrough PONV
Other Names:
  • Compro
Drug: Sugammadex
Reversal with sugammadex
Other Names:
  • Bridion
Drug: Fentanyl
intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
Drug: Aprepitant 80 mg Oral Capsule
aprepitant 80 mg orally one hour prior to scheduled surgery
Other Names:
  • Emend
Drug: Propofol
Intravenous anesthesia will be maintained through IV propofol
Other Names:
  • Diprivan
Drug: dexmedetomidine
maintenance of anesthesia in the intervention arm
Other Names:
  • Precedex
Active Comparator: Control Arm

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
Dexamethasone 8 mg intraoperatively
Drug: Ondansetron
Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
Other Names:
  • Zofran
Drug: Reglan
Postoperatively scheduled Reglan
Other Names:
  • Metoclopramide
Drug: Ondansetron
Postoperatively scheduled ondansetron
Other Names:
  • Zofran
Drug: Compazine
Postoperatively as needed compazine for breakthrough PONV
Other Names:
  • Compro
Drug: Sugammadex
Reversal with sugammadex
Other Names:
  • Bridion
Drug: Sevoflurane
inhalational anesthesia
Other Names:
  • Ultane
Drug: Desflurane
inhalational anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With PONV-related Delay of Hospital Discharge
Time Frame: up to 1 week post-operation (up to 2 weeks from baseline)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
Time Frame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
The severity of PONV will be measured using a visual analogue scale. [0-10] The higher the value, the worse the outcome.
Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Severity of PONV Measured Using the Rhodes Index
Time Frame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks

The Rhodes Index of Nausea, Vomiting, and Retching (R-INVR) is a validated instrument used to measure the severity of Post-Operative Nausea and Vomiting (PONV). The index comprises eight items, each scored on a scale of 0 to 4, allowing for a total score range of 0 to 32 points .

The scoring of each item on the Rhodes Index is as follows:

0 points represent a minimum level of disturbance, 4 points represent a maximum level of disturbance . The total score from these eight items is summed to represent the severity of PONV, with higher scores indicating worse PONV experience. The index encompasses three subscales named "experience," "occurrence," and "distress" . Each of these subscales contributes to the total score to provide a comprehensive measure of PONV severity. Any score above zero on the R-INVR indicates that the participant experienced nausea .
Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey
Time Frame: 24 hours and 3 weeks
The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. The higher the score, the worse the outcome.
24 hours and 3 weeks
GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey
Time Frame: Baseline, 24 hours and 3 weeks
The GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and sub-scores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.
Baseline, 24 hours and 3 weeks
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Time Frame: Baseline, 24 hours and 3 weeks

EQ-5D Descriptive System:

Dimensions: Includes five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.

Levels: Each dimension has 5 severity levels:

  1. No problems
  2. Slight problems
  3. Moderate problems
  4. Severe problems
  5. Extreme problems

Time Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks.
Baseline, 24 hours and 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Konstantinos Spaniolas, MD, Stony Brook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2017

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1074296-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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