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

Primary Purpose

Post-operative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aprepitant 80Mg Oral Capsule
scopolamine transdermal
Total intravenous anesthesia
Dexamethasone
Ondansetron
Reglan
Ondansetron
Compazine
Sugammadex
Propofol
dexmedetomidine
Fentanyl
Sevoflurane
Desflurane
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-operative Nausea and Vomiting focused on measuring Bariatric Procedure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stony Brook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of 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.

Secondary Outcome Measures

Severity of PONV measured using a visual analogue scale
The severity of PONV will be measured using a visual analogue scale.
Severity of PONV measured using the Rhodes Index
The severity of PONV will be measured using the Rhodes Index.
Quality of recovery measured using the QoR-15 survey
The quality of recovery from laparoscopic sleeve gastrectomy will be measured using the QoR-15 survey
GI specific quality of life using the GIQLI survey
Patients will be assessed for any perioperative changed in their quality of life using the GIQLI survey.
Overall quality of life using the EQ-5D instrument
Patients will be assessed for any perioperative changed in their quality of life using the EQ-5D instrument.

Full Information

First Posted
August 14, 2017
Last Updated
March 11, 2022
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT03435003
Brief Title
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Official Title
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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 82. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy
Keywords
Bariatric Procedure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aprepitant 80Mg Oral Capsule
Other Intervention Name(s)
Emend
Intervention Description
aprepitant 80 mg orally one hour prior to scheduled surgery
Intervention Type
Drug
Intervention Name(s)
scopolamine transdermal
Other Intervention Name(s)
Transderm Scop
Intervention Description
scopolamine transdermal patch one hour prior to scheduled surgery
Intervention Type
Procedure
Intervention Name(s)
Total intravenous anesthesia
Intervention Description
Maintenance of anesthesia without the use of inhaled anesthetics.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 8 mg intraoperatively
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
Intervention Type
Drug
Intervention Name(s)
Reglan
Other Intervention Name(s)
Metoclopramide
Intervention Description
Postoperatively scheduled Reglan
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Postoperatively scheduled ondansetron
Intervention Type
Drug
Intervention Name(s)
Compazine
Other Intervention Name(s)
Compro
Intervention Description
Postoperatively as needed compazine for breakthrough PONV
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion
Intervention Description
Reversal with sugammadex
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Intravenous anesthesuia will be maintained through IV propofol
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
maintainance of anesthesia in the intervention arm
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Ultane
Intervention Description
inhalational anesthesia
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
inhalational anesthesia
Primary Outcome Measure Information:
Title
Incidence of PONV-related delay of hospital discharge
Description
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.
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
Severity of PONV measured using a visual analogue scale
Description
The severity of PONV will be measured using a visual analogue scale.
Time Frame
Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Title
Severity of PONV measured using the Rhodes Index
Description
The severity of PONV will be measured using the Rhodes Index.
Time Frame
Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Title
Quality of recovery measured using the QoR-15 survey
Description
The quality of recovery from laparoscopic sleeve gastrectomy will be measured using the QoR-15 survey
Time Frame
24 hours and 3 weeks
Title
GI specific quality of life using the GIQLI survey
Description
Patients will be assessed for any perioperative changed in their quality of life using the GIQLI survey.
Time Frame
Baseline, 24 hours and 3 weeks
Title
Overall quality of life using the EQ-5D instrument
Description
Patients will be assessed for any perioperative changed in their quality of life using the EQ-5D instrument.
Time Frame
Baseline, 24 hours and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8191
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33528788
Citation
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.
Results Reference
derived

Learn more about this trial

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

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