The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Lidocaine
- Conditions
- Atrial Fibrillation
- Sponsor
- The Cleveland Clinic
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- atrial fibrillation
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Intravenous Lidocaine group
Intervention: Lidocaine
Placebo
Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
Intervention: Placebo
Outcomes
Primary Outcomes
atrial fibrillation
Time Frame: postoperatively
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.
mortality
Time Frame: 30 days post surgery
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.