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Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TIVA NoNarc
Sponsored by
Coastal Anesthesiology Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Bariatric Surgery, TIVA, PONV, non-opioid, OSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.

Exclusion Criteria:

  • Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.

Sites / Locations

  • Flagler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Balanced Anesthesia

NoNarc TIVA

Arm Description

Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.

Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine

Outcomes

Primary Outcome Measures

PONV During the First 24 Hours After Bariatric Surgery
Postoperative Nausea and Vomiting

Secondary Outcome Measures

Number of Patients Requiring Antiemetic Rescue Medication (AERM)
PONV Between Different Surgical Procedures (Percentage of Participants)

Full Information

First Posted
October 6, 2011
Last Updated
February 19, 2016
Sponsor
Coastal Anesthesiology Consultants
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1. Study Identification

Unique Protocol Identification Number
NCT01449708
Brief Title
Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
Official Title
Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coastal Anesthesiology Consultants

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases. Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication. Our study hypothesis is that different types of anesthetics reduce PONV further. Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA). The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.
Detailed Description
See above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Bariatric Surgery, TIVA, PONV, non-opioid, OSA

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Balanced Anesthesia
Arm Type
No Intervention
Arm Description
Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.
Arm Title
NoNarc TIVA
Arm Type
Active Comparator
Arm Description
Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine
Intervention Type
Drug
Intervention Name(s)
TIVA NoNarc
Intervention Description
patients in both groups receive antiemetic prophylaxis patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively postop management in both groups is similar in both groups
Primary Outcome Measure Information:
Title
PONV During the First 24 Hours After Bariatric Surgery
Description
Postoperative Nausea and Vomiting
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of Patients Requiring Antiemetic Rescue Medication (AERM)
Time Frame
24hours
Title
PONV Between Different Surgical Procedures (Percentage of Participants)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent. Exclusion Criteria: Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Ziemann-Gimmel, MD
Organizational Affiliation
Coastal Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flagler Hospital
City
St. Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24554545
Citation
Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
Results Reference
derived

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Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery

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