Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery - Full Text View

Sponsor:	Outcomes Research Consortium
Information provided by:	Outcomes Research Consortium
ClinicalTrials.gov Identifier:	NCT00840918

Purpose

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 delirium after surgery. Participants undergoing cardiac surgery will be randomized to receive either lidocaine or placebo.

Condition	Intervention
Atrial Fibrillation Post-Operative Delirium	Drug: Lidocaine Other: Placebo

Study Type:	Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Delirium Heart Surgery

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:

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.
atrial fibrillation [ 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 atrial fibrillation compared to an intravenous saline control.

Secondary Outcome Measures:

postoperative delirium [ Time Frame: pre-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 postoperative delirium
postoperative delerium [ Time Frame: day 1 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 postoperative delirium
postoperative delerium [ Time Frame: day 2 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 postoperative delirium
post operative delerium [ Time Frame: day 3 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 postoperative delirium
post operative delerium [ Time Frame: day 4 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 postoperative delirium

Estimated Enrollment:	1294
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Intravenous Lidocaine group	Drug: Lidocaine < 70 years - lidocaine 1.5 mg/kg up to a maximum of 150% of IBW. Lidocaine 2 mg/kg/hour,a maximum of 120% of IBW,for three hours. Lidocaine reduced to 1.0 mg/kg/hour,maximum of 120% of IBW, discontinued 24 hours postoperatively. Patients 70 yrs-Lidocaine 1 mg/kg up to a maximum of 150% of IBW, Lidocaine 1.5 mg/kg/hour maximum of 120% of IBW for three hours. Lidocaine reduced to 0.8 mg/kg/hour, maximum of 120% of IBW,discontinued 24 hours postoperatively. Patients 80s-lidocaine 1 mg/kg equal to the lesser of ABW or IBW lidocaine 1.5 mg/kg/hour using the lesser of ABW or IBW will be infused for three hours. Lidocaine reduced to 0.8 mg/kg/hour using the lesser of ABW or IBW/ discontinued 24 hours postoperatively. In all patient groups, the lidocaine infusion will be reduced by 50% for patients with persistently reduced cardiac output defined as a cardiac index consistently < 1.8 for longer than 60 minutes. Drug: Lidocaine 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	Other: Placebo Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

Arms

Assigned Interventions

Active Comparator: 1

Intravenous Lidocaine group

Drug: Lidocaine

< 70 years - lidocaine 1.5 mg/kg up to a maximum of 150% of IBW. Lidocaine 2 mg/kg/hour,a maximum of 120% of IBW,for three hours. Lidocaine reduced to 1.0 mg/kg/hour,maximum of 120% of IBW, discontinued 24 hours postoperatively.

Patients 70 yrs-Lidocaine 1 mg/kg up to a maximum of 150% of IBW, Lidocaine 1.5 mg/kg/hour maximum of 120% of IBW for three hours. Lidocaine reduced to 0.8 mg/kg/hour, maximum of 120% of IBW,discontinued 24 hours postoperatively.

Patients 80s-lidocaine 1 mg/kg equal to the lesser of ABW or IBW lidocaine 1.5 mg/kg/hour using the lesser of ABW or IBW will be infused for three hours. Lidocaine reduced to 0.8 mg/kg/hour using the lesser of ABW or IBW/ discontinued 24 hours postoperatively.

In all patient groups, the lidocaine infusion will be reduced by 50% for patients with persistently reduced cardiac output defined as a cardiac index consistently < 1.8 for longer than 60 minutes.

Drug: Lidocaine

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

Other: Placebo

Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

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 cognitive assessments,quality of life assessments and functional recovery assessments post-surgery.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840918

Contacts

Contact: Gretchen Upton

216-444-3289

uptong@ccf.org

Locations

India
SAL Hospital	Recruiting
Gujarat, Ahmedabad,, India, 380 054
Contact: Dhruti Trivedi +91-79-4005 4103 dtrivedi@heartcareassociates.in
Principal Investigator: Anil Jain, M.D.

Sponsors and Collaborators

Outcomes Research Consortium

Investigators

Principal Investigator:	Martin Grady, M.D.	The Cleveland Clinic
Study Chair:	Daniel I Sessler, M.D.	The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Martin Grady, M.D., Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00840918 History of Changes
Other Study ID Numbers:	08-861
Study First Received:	February 10, 2009
Last Updated:	October 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:

Cardiac surgery
Lidocaine
Quality of life
Cognitive assessments

Additional relevant MeSH terms:

Atrial Fibrillation
Delirium
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2012