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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Intravenous Lidocaine group |
|
| Placebo | Placebo Comparator | Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Grady, M.D. | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, M.D. | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SAL Hospital | Ahmedabad | Gujarat | 380 054 | India |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Other | Placebo is administered intravenously throughout surgery and during the 24 hours following surgery |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |