Lidocaine For Neuroprotection During Cardiac Surgery

Status:	Completed
Conditions:	Cognitive Studies
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	50 - Any
Updated:	6/23/2018
Start Date:	July 2009
End Date:	May 23, 2017

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.

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 -

We found this trial at

sites

Duke Univ Med Ctr

2301 Erwin Rd
Durham, North Carolina 27710

919-684-8111