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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Delirium; Acute Kidney Injury; Cognitive Disorders

Treatments: Drug: Propofol; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02554253

14-007148

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

ketamine

Active Comparator group

Description:

Ketamine induction

Treatment:

Drug: Ketamine

Propofol

Active Comparator group

Description:

Propofol induction

Treatment:

Drug: Propofol