Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

Study Overview
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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.

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.

Official Title
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The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Lidocaine
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Intravenous Lidocaine group | Drug: Lidocaine<br>* Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.<br>|
| Placebo Comparator: Placebo<br>Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery | Other: Placebo<br>* Placebo is administered intravenously throughout surgery and during the 24 hours following surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atrial fibrillation | To test the hypothesis that lidocaine infusion started at induction of anesthesia and maintained for 24 hours postoperatively will decrease the incidence of atrial fibrillation compared to an intravenous saline control. | postoperatively | 
| mortality | To test the hypothesis that lidocaine infusion started at induction of anesthesia and maintained for 24 hours postoperatively will decrease the incidence of 30 day mortality as compared to an intravenous saline control. | 30 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Lidocaine, Quality of life