Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

The Cleveland Clinic123 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

123

Conditions

Atrial Fibrillation

Interventions

LidocaineDRUG

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

SAL Hospital

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 days post surgery

Data from ClinicalTrials.gov

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