CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 550 enrolled
Drug / intervention
Lidocaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00938964
NCT00938964N/ACompleted
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Lidocaine For Neuroprotection During Cardiac Surgery

Duke University·interventional·Posted Jul 14, 2009·Updated May 10, 2019

In Brief

A clinical study evaluating Lidocaine and Placebo for Cognitive Decline. Completed, enrolled 550 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCognitive Decline
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), CAS Medical Systems, Inc.

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2009
Enrollment StartJul 1, 2009
Primary CompletionJul 18, 2016
Study CompletionMay 23, 2017
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 17.0 years ago

Interventions

Lidocainedrug

Lidocaine versus placebo infusion for 48 hours

Placebodrug

Lidocaine versus placebo infusion for 48 hours