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

NCT02554253 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 14-007148
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Disorders; Delirium; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Postoperative Cognitive Dysfunction

  Pre and postoperative cognitive studies will be performed to assess change in cognitive function. Postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of \>1 standard deviation (i.e. z-score decline of \> 1) on at least 2 neurocognitive tests. The neurocognitive tests utilized include Trail making Test A, Trail making Test B, Hopkins Verbal Learning Test-Revised Learning trials, Hopkins Verbal Learning Test-Revised Delayed Recall, Digit Span, Controlled Oral Word Association Test, Stroop color/word test, and the Mini Mental Status Examination.

  Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first.

Secondary Outcomes (2)

• Number of Patients With Acute Kidney Injury

  Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first.

• Number of Patients Who Develop Postoperative Delirium

  Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first.

Study Arms (2)

ketamine

ACTIVE COMPARATOR

Ketamine induction

Drug: Ketamine

Propofol

ACTIVE COMPARATOR

Propofol induction

Drug: Propofol

Interventions

Ketamine DRUG

Ketamine used for induction

Also known as: Ketalar

ketamine

Propofol DRUG

Propofol for induction

Also known as: Diprivan, Propoven

Propofol

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cognitive Dysfunction; Delirium; Acute Kidney Injury

Interventions

Ketamine; Propofol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Limitations and Caveats

Not powered to detect differences in acute kidney injury. A larger study will be needed.

Results Point of Contact

• Title: Erica Wittwer
• Organization: Mayo Clinic

wittwer.erica@mayo.edu

5072559814

Study Officials

• Erica Wittwer, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 18, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 15, 2022
• Results First Posted: February 15, 2022

Record last verified: 2022-01

Locations

US (1)