Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery|
- atrial fibrillation [ Time Frame: postoperatively ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Intravenous Lidocaine group
Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.
Placebo Comparator: Placebo
Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840918
|Contact: Gretchen Uptonfirstname.lastname@example.org|
|Gujarat, Ahmedabad,, India, 380 054|
|Contact: Dhruti Trivedi +91-79-4005 4103 email@example.com|
|Principal Investigator: Anil Jain, M.D.|
|Principal Investigator:||Martin Grady, M.D.||The Cleveland Clinic|
|Study Chair:||Daniel I Sessler, M.D.||The Cleveland Clinic|