A Study of the Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 14-007148
    NCT ID: NCT02554253
    Sponsor Protocol Number: 14-007148

About this study

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 with propofol will be investigated.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Scheduled to undergo cardiac surgery

Inclusion Criteria:

  • Age greater than or equal to 70 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:

  • 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 2.0 mg/dL or requiring dialysis
  • Immunosuppressive medication use (including steroid use)
  • Immunodeficiency syndrome
  • Known neurologic or psychiatric disorder or
  • Use of drugs for psychosis

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Erica Wittwer, M.D., Ph.D.

Open for enrollment

Contact information:

Lavonne Liedl R.R.T.

(507)255-1828

liedl.Lavonne@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20152422

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