Back to resultsIntravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Cardiac surgery, Lidocaine, Quality of life
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
Sites / Locations
- SAL Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
Placebo
Arm Description
Intravenous Lidocaine group
Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00840918
Brief Title
Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery
Official Title
The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Problem with enrollment
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 15, 2014 (Actual)
Study Completion Date
December 15, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Cardiac surgery, Lidocaine, Quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Intravenous Lidocaine group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
Primary Outcome Measure Information:
Title
atrial fibrillation
Description
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.
Time Frame
postoperatively
Title
mortality
Description
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.
Time Frame
30 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Grady, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel I Sessler, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
SAL Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 054
Country
India
12. IPD Sharing Statement
Learn more about this trial
Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery
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