Lidocaine For Neuroprotection During Cardiac Surgery

Duke University

Status: Completed

Conditions: Cognitive Decline

Treatments: Drug: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00938964

Pro00015641

R01HL096978 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 550 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

550 participants in 2 patient groups, including a placebo group

Lidocaine

Experimental group

Description:

Lidocaine infusion for 48 hours

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

Normal saline infusion for 48 hours

Treatment:

Drug: Placebo