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NCT Number: NCT03435003

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

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.

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Key information

Conditions

Post-operative Nausea and Vomiting Laparoscopic Sleeve Gastrectomy Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stony Brook University Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant 80 mg Oral Capsule

Drug

aprepitant 80 mg orally one hour prior to scheduled surgery

Other names: Emend

scopolamine transdermal

Drug

scopolamine transdermal patch one hour prior to scheduled surgery

Other names: Transderm Scop

Total intravenous anesthesia

Procedure

Maintenance of anesthesia without the use of inhaled anesthetics.

Dexamethasone

Drug

Dexamethasone 8 mg intraoperatively

ondansetron

Drug

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

Other names: Zofran

Reglan

Drug

Postoperatively scheduled Reglan

Other names: Metoclopramide

Compazine

Drug

Postoperatively as needed compazine for breakthrough PONV

Other names: Compro

Sugammadex

Drug

Reversal with sugammadex

Other names: Bridion

Propofol

Drug

Intravenous anesthesia will be maintained through IV propofol

Other names: Diprivan

Dexmedetomidine

Drug

maintenance of anesthesia in the intervention arm

Other names: Precedex

Fentanyl

Drug

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

Sevoflurane

Drug

inhalational anesthesia

Other names: Ultane

Desflurane

Drug

inhalational anesthesia

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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 .

  3. 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.

  4. 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.

  5. 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:

    • No problems
    • Slight problems
    • Moderate problems
    • Severe problems
    • Extreme problems

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

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2018
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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