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

This study has been completed.
Information provided by (Responsible Party):
Patrick Ziemann-Gimmel, Coastal Anesthesiology Consultants Identifier:
First received: October 6, 2011
Last updated: February 19, 2016
Last verified: February 2016

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 Intervention Phase
Postoperative Nausea and Vomiting
Drug: TIVA NoNarc
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery

Resource links provided by NLM:

Further study details as provided by Coastal Anesthesiology Consultants:

Primary Outcome Measures:
  • PONV During the First 24 Hours After Bariatric Surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Postoperative Nausea and Vomiting

Secondary Outcome Measures:
  • Number of Patients Requiring Antiemetic Rescue Medication (AERM) [ Time Frame: 24hours ] [ Designated as safety issue: No ]
  • PONV Between Different Surgical Procedures (Percentage of Participants) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: November 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
See above

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01449708

United States, Florida
Flagler Hospital
St. Augustine, Florida, United States, 32086
Sponsors and Collaborators
Coastal Anesthesiology Consultants
Principal Investigator: Patrick Ziemann-Gimmel, MD Coastal Anesthesiology
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Patrick Ziemann-Gimmel, MD, Anesthesiologist, Principal Investigator, Coastal Anesthesiology Consultants Identifier: NCT01449708     History of Changes
Other Study ID Numbers: 3766 - 6886 
Study First Received: October 6, 2011
Results First Received: February 27, 2015
Last Updated: February 19, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Coastal Anesthesiology Consultants:
Bariatric Surgery

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on October 21, 2016