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The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction

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: NCT02554253
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Erica D. Wittwer, M.D., Ph.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 16, 2015
First Posted Date  ICMJE September 18, 2015
Last Update Posted Date March 17, 2021
Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
Number of patients with postoperative cognitive dysfunction [ Time Frame: Baseline to one month ]
Pre and postoperative cognitive studies will be performed to assess change in cognitive function.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
  • Number of patients with acute kidney injury [ Time Frame: Baseline to one month ]
  • Number of patients who develop postoperative delirium [ Time Frame: Baseline to one month ]
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 The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
Official Title  ICMJE The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction in Patients 75 Years of Age or Older and Undergoing Cardiac Surgery
Brief Summary Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia as well as as an analgesic. It has been shown to have anti-inflammatory properties which may decrease post-operative complications following cardiac surgery with cardiopulmonary bypass that are thought to associated with inflammation. Some studies have shown that ketamine does decrease these complications when compared with anesthetics that are not commonly used in our cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication which is used for induction of anesthesia. Ketamine has not been compared with propofol for potential to reduce post-operative complications associated with the inflammatory process. This study aims to see if ketamine will reduce the incidence of cognitive dysfunction, delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic impact of ketamine compared propofol will be investigated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cognitive Disorders
  • Delirium
  • Acute Kidney Injury
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine used for induction
    Other Name: Ketalar
  • Drug: Propofol
    Propofol for induction
    Other Names:
    • Diprivan
    • Propoven
Study Arms  ICMJE
  • Active Comparator: ketamine
    Ketamine induction
    Intervention: Drug: Ketamine
  • Active Comparator: Propofol
    Propofol induction
    Intervention: Drug: Propofol
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2015)
52
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Scheduled to undergo cardiac surgery.

Inclusion criteria:

  • age greater than or equal to 75 years presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota;
  • schedule to undergo complex cardiac surgery. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and CABG procedures.

Exclusion criteria will include:

  • left or right ventricular assist device implantation or explantation,
  • procedures not requiring cardiopulmonary bypass,
  • active infection or sepsis, severe hepatic disease or ascites,
  • pre-operative renal dysfunction including a baseline creatinine equal to or greater than 1.5 mg/dL or requiring dialysis,
  • immunosuppressive medication use (including steroid use),
  • immunodeficiency syndrome,
  • known neurologic or psychiatric disorder, or
  • use of drugs for psychosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years and older   (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 NCT02554253
Other Study ID Numbers  ICMJE 14-007148
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erica D. Wittwer, M.D., Ph.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erica Wittwer, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2021

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