Overview

Lidocaine For Neuroprotection During Cardiac Surgery

Status:
Completed

Trial end date:
2017-05-23

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking nerves). The investigators are enrolling subjects in this research project to see if lidocaine will reduce the high incidence of cognitive injury seen after heart surgery. As part of this study, the investigators will also evaluate the relationship between cognitive injury and genetic makeup and the chemical changes in the subjects blood during and after surgery.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Duke University

Collaborators:

CAS Medical Systems, Inc.
National Heart, Lung, and Blood Institute (NHLBI)

Treatments:

Lidocaine

Criteria

Inclusion Criteria:

1. CABG, CABG + Valve, or Valve surgery

2. Use of cardiopulmonary bypass

Exclusion Criteria:

1. Less than 50 years of age

2. History of diabetes

3. History of symptomatic cerebrovascular disease (e.g. prior stroke) with residual
deficit

4. Alcoholism (> 2 drinks/day)

5. History of psychiatric illness (any clinical diagnoses requiring therapy)

6. History of drug abuse (any illicit drug use in the past 3 months)

7. Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)

8. Severe pulmonary insufficiency (requiring home oxygen therapy)

9. Renal failure (baseline serum creatinine > 2.0 mg/dl)

10. Pregnant women

11. Unable to read and thus unable to complete the cognitive testing

12. Score < 24 on a baseline Mini Mental State examination (MMSE) or greater than or equal
to 27 on the baseline Center for Epidemiological Studies Depression (CES-D) Scale -