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

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ClinicalTrials.gov Identifier: NCT02554253
Recruitment Status : Recruiting
First Posted : September 18, 2015
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Erica D. Wittwer, M.D., Ph.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Cognitive Disorders Delirium Acute Kidney Injury Drug: Ketamine Drug: Propofol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction in Patients 75 Years of Age or Older and Undergoing Cardiac Surgery
Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: ketamine
Ketamine induction
Drug: Ketamine
Ketamine used for induction
Other Name: Ketalar

Active Comparator: Propofol
Propofol induction
Drug: Propofol
Propofol for induction
Other Names:
  • Diprivan
  • Propoven




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of patients with acute kidney injury [ Time Frame: Baseline to one month ]
  2. Number of patients who develop postoperative delirium [ Time Frame: Baseline to one month ]


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554253


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lavonne Liedl    507-255-1828      
Principal Investigator: Erica Wittwer, MD, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Erica Wittwer, MD, PhD Mayo Clinic

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Responsible Party: Erica D. Wittwer, M.D., Ph.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02554253     History of Changes
Other Study ID Numbers: 14-007148
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Delirium
Acute Kidney Injury
Cognitive Dysfunction
Renal Insufficiency
Cognition Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Kidney Diseases
Urologic Diseases
Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action