Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00840918
Status:
TERMINATED
Last Update Posted:
2019-03-29
First Post:
2009-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Problem with enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: