Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT00840918|
Recruitment Status : Recruiting
First Posted : February 11, 2009
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Lidocaine Other: Placebo||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||1294 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840918
|Contact: Roberta Johnsonfirstname.lastname@example.org|
|Ahmedabad, Gujarat, 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|