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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Ziemann-Gimmel, Coastal Anesthesiology Consultants
ClinicalTrials.gov Identifier:
NCT01449708
First received: October 6, 2011
Last updated: February 24, 2014
Last verified: October 2012
  Purpose

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 48 hours after bariatric surgery [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction with perioperative treatment [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 125
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449708

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

Additional Information:
No publications provided by Coastal Anesthesiology Consultants

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrick Ziemann-Gimmel, MD, Anesthesiologist, Principal Investigator, Coastal Anesthesiology Consultants
ClinicalTrials.gov Identifier: NCT01449708     History of Changes
Other Study ID Numbers: 3766 - 6886
Study First Received: October 6, 2011
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Coastal Anesthesiology Consultants:
Bariatric Surgery
TIVA
PONV
non-opioid
OSA

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014