Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 6, 2011
First Posted Date  ICMJE October 10, 2011
Results First Submitted Date  ICMJE February 27, 2015
Results First Posted Date  ICMJE March 21, 2016
Last Update Posted Date March 21, 2016
Study Start Date  ICMJE November 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
PONV During the First 24 Hours After Bariatric Surgery [ Time Frame: 24 hours ]
Postoperative Nausea and Vomiting
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2011)
PONV during the first 48 hours after bariatric surgery [ Time Frame: 48 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • Number of Patients Requiring Antiemetic Rescue Medication (AERM) [ Time Frame: 24hours ]
  • PONV Between Different Surgical Procedures (Percentage of Participants) [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2011)
Patient satisfaction with perioperative treatment [ Time Frame: 48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
Official Title  ICMJE Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Nausea and Vomiting
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: TIVA NoNarc
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2016)
124
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2011)
150
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01449708
Other Study ID Numbers  ICMJE 3766 - 6886
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Patrick Ziemann-Gimmel, Coastal Anesthesiology Consultants
Study Sponsor  ICMJE Coastal Anesthesiology Consultants
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Ziemann-Gimmel, MD Coastal Anesthesiology
PRS Account Coastal Anesthesiology Consultants
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP