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Ketamine in Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT01724983
Recruitment Status : Unknown
Verified November 2012 by University of Padova.
Recruitment status was:  Active, not recruiting
First Posted : November 12, 2012
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):
University of Padova

Tracking Information
First Submitted Date  ICMJE September 14, 2012
First Posted Date  ICMJE November 12, 2012
Last Update Posted Date November 12, 2012
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2012)
  • pain level [ Time Frame: postoperatively, up to 3 months ]
  • mood level [ Time Frame: postoperatively, up to 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2012)
  • total dosages of analgesic and muscle relaxant drugs [ Time Frame: postoperatively, up to 3 months ]
  • postanesthetic recovery [ Time Frame: postoperatively, up to 24 hours ]
  • satisfaction of the patient and of the surgeon [ Time Frame: day 1 ]
  • pulse oximetry saturation [ Time Frame: postoperatively, up to 24 hours ]
  • lung volumes [ Time Frame: postoperatively, up to 48 hours from end of surgery ]
  • antihemetic drug dosage [ Time Frame: postoperatively, up to 24 hours ]
  • vasoactive drugs [ Time Frame: intraoperatively and up to 24 hours from surgery end ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine in Bariatric Surgery
Official Title  ICMJE Effects of Ketamine on Recovery From Bariatric Surgery
Brief Summary Ketamine may improve recovery from bariatric surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE
  • Drug: ketamine
  • Drug: fentanyl
Study Arms  ICMJE
  • Experimental: ketamine
    patients will receive ketamine at induction
    Intervention: Drug: ketamine
  • Active Comparator: fentanyl
    patients will receive fentanyl at induction
    Intervention: Drug: fentanyl
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 7, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age > 18
  • obesity (Body Mass Index > 30)
  • ASA classificazion < 4
  • candidate to bariatric surgery

Exclusion Criteria:

  • known or presumed pregnancy
  • previous surgery on the airway, esophagus or stomach
  • uncontrolled psychiatric symptomatology
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01724983
Other Study ID Numbers  ICMJE KET2271
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Padova
Study Sponsor  ICMJE University of Padova
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulderico Freo, MD University of Padova
PRS Account University of Padova
Verification Date November 2012

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