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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cognitive Disorders Delirium Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ketamine

Ketamine induction

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Ketamine used for induction

Propofol

Propofol induction

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol for induction

Interventions

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Ketamine

Ketamine used for induction

Intervention Type DRUG

Propofol

Propofol for induction

Intervention Type DRUG

Other Intervention Names

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Ketalar Diprivan Propoven

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No