Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-12-15

Brief Summary

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This study is being done to determine if lidocaine, administered during surgery and for 24 hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation and 30 day mortality after surgery. Participants undergoing cardiac surgery will be randomized to receive either lidocaine or placebo.

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Detailed Description

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Subjects undergoing cardiac surgery are randomized into one of two groups.

* Group 1: Intravenous Lidocaine Group
* Group 2: Intravenous placebo Group

Either Lidocaine or placebo is administered throughout surgery and 24 hours after surgery.

Patients in both groups will undergo quality of life assessments and functional recovery assessments post-surgery.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Intravenous Lidocaine group

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.

Placebo

Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

Interventions

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Lidocaine

Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.

Intervention Type DRUG

Placebo

Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-90 years old
* Scheduled for cardiac surgery requiring cardiopulmonary bypass
* Written informed consent

Exclusion Criteria

* Off-pump surgical procedures
* Anticipated deep hypothermic circulatory arrest
* Any contraindications to the proposed interventions including lidocaine allergy
* History of preoperative atrial fibrillation
* Baseline Screening revealing preexisting dementia or delirium
* Preoperative liver failure defined as Child-Pugh Score \> 6

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No