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

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ClinicalTrials.gov Identifier: NCT01449708
Recruitment Status : Completed
First Posted : October 10, 2011
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Patrick Ziemann-Gimmel, Coastal Anesthesiology Consultants

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: TIVA NoNarc Phase 4

Detailed Description:
See above
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery
Study Start Date : November 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Balanced Anesthesia
Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.
Active Comparator: NoNarc TIVA
Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine
 Drug: TIVA NoNarc
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. PONV During the First 24 Hours After Bariatric Surgery [ Time Frame: 24 hours ]
    Postoperative Nausea and Vomiting


Secondary Outcome Measures :
  1. Number of Patients Requiring Antiemetic Rescue Medication (AERM) [ Time Frame: 24hours ]
  2. PONV Between Different Surgical Procedures (Percentage of Participants) [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449708


Locations
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United States, Florida
Flagler Hospital
St. Augustine, Florida, United States, 32086
Sponsors and Collaborators
Coastal Anesthesiology Consultants
Investigators
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Principal Investigator: Patrick Ziemann-Gimmel, MD Coastal Anesthesiology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Patrick Ziemann-Gimmel, MD, Anesthesiologist, Principal Investigator, Coastal Anesthesiology Consultants
ClinicalTrials.gov Identifier: NCT01449708    
Other Study ID Numbers: 3766 - 6886
First Posted: October 10, 2011    Key Record Dates
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Patrick Ziemann-Gimmel, Coastal Anesthesiology Consultants:
Bariatric Surgery
TIVA
PONV
non-opioid
OSA
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
 Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes