Intravenous Lidocaine Does Not Improve Neurologic Outcomes after Cardiac Surgery: A Randomized Controlled Trial
WHAT WE ALREADY KNOW ABOUT THIS TOPICPreclinical and clinical studies suggest that lidocaine might be neuroprotective, which could benefit surgical patients at risk of neurologic compromise WHAT THIS ARTICLE TELLS US THAT IS NEWThis multicenter trial of intravenous lidocaine administered during and...
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| Published in | Anesthesiology (Philadelphia) Vol. 130; no. 6; pp. 958 - 970 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Copyright by , the American Society of Anesthesiologists, Inc. Wolters Kluwer Health, Inc
01.06.2019
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| Subjects | |
| Online Access | Get full text |
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| Abstract | WHAT WE ALREADY KNOW ABOUT THIS TOPICPreclinical and clinical studies suggest that lidocaine might be neuroprotective, which could benefit surgical patients at risk of neurologic compromise
WHAT THIS ARTICLE TELLS US THAT IS NEWThis multicenter trial of intravenous lidocaine administered during and after cardiac surgery did not show an effect on cognition at 6 weeks postoperatively
BACKGROUND:Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest that intravenous lidocaine may confer protection in the setting of neurologic injury. It was hypothesized that lidocaine administration would reduce cognitive decline after cardiac surgery compared to placebo.
METHODS:After institutional review board approval, 478 patients undergoing cardiac surgery were enrolled into this multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group trial. Subjects were randomized to lidocaine 1 mg/kg bolus after the induction of anesthesia followed by a continuous infusion (48 μg · kg · min for the first hour, 24 μg · kg · min for the second hour, and 10 μg · kg · min for the next 46 h) or saline with identical volume and rate changes to preserve blinding. Cognitive function was assessed preoperatively and at 6 weeks and 1 yr postoperatively using a standard neurocognitive test battery. The primary outcome was change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type.
RESULTS:Among the 420 allocated subjects who returned for 6-week follow-up (lidocaineN = 211; placeboN = 209), there was no difference in the continuous cognitive score change (adjusted mean difference [95% CI], 0.02 (−0.05, 0.08); P = 0.626). Cognitive deficit (greater than 1 SD decline in at least one cognitive domain) at 6 weeks occurred in 41% (87 of 211) in the lidocaine group versus 40% (83 of 209) in the placebo group (adjusted odds ratio [95% CI], 0.94 [0.63, 1.41]; P = 0.766). There were no differences in any quality of life outcomes between treatment groups. At the 1-yr follow-up, there continued to be no difference in cognitive score change, cognitive deficit, or quality of life.
CONCLUSIONS:Intravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks. |
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| AbstractList | In a large cohort of non-diabetic cardiac surgical patients, intravenous lidocaine failed to alter cognitive outcomes at 6 weeks after surgery. WHAT WE ALREADY KNOW ABOUT THIS TOPICPreclinical and clinical studies suggest that lidocaine might be neuroprotective, which could benefit surgical patients at risk of neurologic compromise WHAT THIS ARTICLE TELLS US THAT IS NEWThis multicenter trial of intravenous lidocaine administered during and after cardiac surgery did not show an effect on cognition at 6 weeks postoperatively BACKGROUND:Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest that intravenous lidocaine may confer protection in the setting of neurologic injury. It was hypothesized that lidocaine administration would reduce cognitive decline after cardiac surgery compared to placebo. METHODS:After institutional review board approval, 478 patients undergoing cardiac surgery were enrolled into this multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group trial. Subjects were randomized to lidocaine 1 mg/kg bolus after the induction of anesthesia followed by a continuous infusion (48 μg · kg · min for the first hour, 24 μg · kg · min for the second hour, and 10 μg · kg · min for the next 46 h) or saline with identical volume and rate changes to preserve blinding. Cognitive function was assessed preoperatively and at 6 weeks and 1 yr postoperatively using a standard neurocognitive test battery. The primary outcome was change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type. RESULTS:Among the 420 allocated subjects who returned for 6-week follow-up (lidocaineN = 211; placeboN = 209), there was no difference in the continuous cognitive score change (adjusted mean difference [95% CI], 0.02 (−0.05, 0.08); P = 0.626). Cognitive deficit (greater than 1 SD decline in at least one cognitive domain) at 6 weeks occurred in 41% (87 of 211) in the lidocaine group versus 40% (83 of 209) in the placebo group (adjusted odds ratio [95% CI], 0.94 [0.63, 1.41]; P = 0.766). There were no differences in any quality of life outcomes between treatment groups. At the 1-yr follow-up, there continued to be no difference in cognitive score change, cognitive deficit, or quality of life. CONCLUSIONS:Intravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks. Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest that intravenous lidocaine may confer protection in the setting of neurologic injury. It was hypothesized that lidocaine administration would reduce cognitive decline after cardiac surgery compared to placebo. After institutional review board approval, 478 patients undergoing cardiac surgery were enrolled into this multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group trial. Subjects were randomized to lidocaine 1 mg/kg bolus after the induction of anesthesia followed by a continuous infusion (48 μg · kg · min for the first hour, 24 μg · kg · min for the second hour, and 10 μg · kg · min for the next 46 h) or saline with identical volume and rate changes to preserve blinding. Cognitive function was assessed preoperatively and at 6 weeks and 1 yr postoperatively using a standard neurocognitive test battery. The primary outcome was change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type. Among the 420 allocated subjects who returned for 6-week follow-up (lidocaine: N = 211; placebo: N = 209), there was no difference in the continuous cognitive score change (adjusted mean difference [95% CI], 0.02 (-0.05, 0.08); P = 0.626). Cognitive deficit (greater than 1 SD decline in at least one cognitive domain) at 6 weeks occurred in 41% (87 of 211) in the lidocaine group versus 40% (83 of 209) in the placebo group (adjusted odds ratio [95% CI], 0.94 [0.63, 1.41]; P = 0.766). There were no differences in any quality of life outcomes between treatment groups. At the 1-yr follow-up, there continued to be no difference in cognitive score change, cognitive deficit, or quality of life. Intravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks. Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest that intravenous lidocaine may confer protection in the setting of neurologic injury. It was hypothesized that lidocaine administration would reduce cognitive decline after cardiac surgery compared to placebo.BACKGROUNDCognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest that intravenous lidocaine may confer protection in the setting of neurologic injury. It was hypothesized that lidocaine administration would reduce cognitive decline after cardiac surgery compared to placebo.After institutional review board approval, 478 patients undergoing cardiac surgery were enrolled into this multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group trial. Subjects were randomized to lidocaine 1 mg/kg bolus after the induction of anesthesia followed by a continuous infusion (48 μg · kg · min for the first hour, 24 μg · kg · min for the second hour, and 10 μg · kg · min for the next 46 h) or saline with identical volume and rate changes to preserve blinding. Cognitive function was assessed preoperatively and at 6 weeks and 1 yr postoperatively using a standard neurocognitive test battery. The primary outcome was change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type.METHODSAfter institutional review board approval, 478 patients undergoing cardiac surgery were enrolled into this multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group trial. Subjects were randomized to lidocaine 1 mg/kg bolus after the induction of anesthesia followed by a continuous infusion (48 μg · kg · min for the first hour, 24 μg · kg · min for the second hour, and 10 μg · kg · min for the next 46 h) or saline with identical volume and rate changes to preserve blinding. Cognitive function was assessed preoperatively and at 6 weeks and 1 yr postoperatively using a standard neurocognitive test battery. The primary outcome was change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type.Among the 420 allocated subjects who returned for 6-week follow-up (lidocaine: N = 211; placebo: N = 209), there was no difference in the continuous cognitive score change (adjusted mean difference [95% CI], 0.02 (-0.05, 0.08); P = 0.626). Cognitive deficit (greater than 1 SD decline in at least one cognitive domain) at 6 weeks occurred in 41% (87 of 211) in the lidocaine group versus 40% (83 of 209) in the placebo group (adjusted odds ratio [95% CI], 0.94 [0.63, 1.41]; P = 0.766). There were no differences in any quality of life outcomes between treatment groups. At the 1-yr follow-up, there continued to be no difference in cognitive score change, cognitive deficit, or quality of life.RESULTSAmong the 420 allocated subjects who returned for 6-week follow-up (lidocaine: N = 211; placebo: N = 209), there was no difference in the continuous cognitive score change (adjusted mean difference [95% CI], 0.02 (-0.05, 0.08); P = 0.626). Cognitive deficit (greater than 1 SD decline in at least one cognitive domain) at 6 weeks occurred in 41% (87 of 211) in the lidocaine group versus 40% (83 of 209) in the placebo group (adjusted odds ratio [95% CI], 0.94 [0.63, 1.41]; P = 0.766). There were no differences in any quality of life outcomes between treatment groups. At the 1-yr follow-up, there continued to be no difference in cognitive score change, cognitive deficit, or quality of life.Intravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks.CONCLUSIONSIntravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks. |
| Author | D’Amico, Thomas A. Klinger, Rebecca Y. Stafford-Smith, Mark Milano, Carmelo A. Smith, Peter K. Li, Yi-Ju Mathew, Joseph P. Toulgoat-Dubois, Yanne Schroeder, Jacob N. Podgoreanu, Mihai V. Cooter, Mary Lin, Shu S. Harpole, David Laskowitz, Daniel T. Waweru, Peter Shearer, Ian Klapper, Jacob A. Kertai, Miklos D. Brassard, Rachele Hughes, G. Chad Plichta, Ryan P. Berger, Miles Graffagnino, Carmelo Babyak, Michael A. Strittmatter, Warren J. Glower, Donald D. Haney, Jack Swaminathan, Madhav Bennett, Ellen R. Newman, Mark F. Daneshmand, Mani A. Karhausen, Jorn A. Welsh-Bohmer, Kathleen A. Sketch, Michael H. Warner, David S. Browndyke, Jeffrey N. Terrando, Niccolò Hartwig, Mathew G. Gaca, Jeffrey G. Tong, Betty C. Smigla, Greg Bisanar, Tiffany Lodge, Andrew J. Funk, Bonita L. Krishnamoorthy, Vijay Blumenthal, James A. Collins, Kevin |
| AuthorAffiliation | From the Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina (R.Y.K., M.C., T.B., N.T., M.B., M.V.P., M.S.-S., J.P.M.) the Department of Anesthesiology, University of Kentucky School of Medicine, Lexington, Kentucky (M.F.N.) |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30870159$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Strittmatter, Warren J Daneshmand, Mani A Li, Yi-Ju Hartwig, Mathew G Toulgoat-Dubois, Yanne Milano, Carmelo A Funk, Bonita L Welsh-Bohmer, Kathleen A Harpole, David Waweru, Peter Laskowitz, Daniel T Shearer, Ian Warner, David S Brassard, Rachele Glower, Donald D Tong, Betty C Lin, Shu S Schroeder, Jacob N Kertai, Miklos D Graffagnino, Carmelo Plichta, Ryan P Babyak, Michael A Blumenthal, James A Klapper, Jacob A Smith, Peter K Karhausen, Jorn A Bennett, Ellen R Haney, Jack Swaminathan, Madhav Sketch, Jr, Michael H Hughes, G Chad Smigla, Greg Lodge, Andrew J D'Amico, Thomas A Browndyke, Jeffrey N Gaca, Jeffrey G Krishnamoorthy, Vijay Collins, Kevin |
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| Copyright | Copyright © by 2019, the American Society of Anesthesiologists, Inc. Wolters Kluwer Health, Inc. All Rights Reserved. |
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| References | (R46-20241219) 1997; 29 (R15-20241219) 1994; 6 (R12-20241219) 2002; 95 (R39-20241219) 2013; 8 (R41-20241219) 1998; 88 (R17-20241219) 2000; 93 (R3-20241219) 1986; 64 (R10-20241219) 2009; 87 (R5-20241219) 1990; 65 (R6-20241219) 1996; 27 (R23-20241219) 2011; 25 (R24-20241219) 1995; 59 (R34-20241219) 1995; 489 (R40-20241219) 2011; 70 (R42-20241219) 1981; 25 (R21-20241219) 2004; 21 (R2-20241219) 2006; 68 (R31-20241219) 1989; 70 (R49-20241219) 2015; 33 (R28-20241219) 1958; 8 (R4-20241219) 1998; 29 (R35-20241219) 1999; 890 (R36-20241219) 1999; 19 (R1-20241219) 2001; 344 (R48-20241219) 2014; 28 (R25-20241219) 1995; 10 (R9-20241219) 1996; 27 (R11-20241219) 2015; 21 (R22-20241219) 2009; 40 (R20-20241219) 1980; 56 (R13-20241219) 1981; 55 (R19-20241219) 2013; 38 (R38-20241219) 1995; 19 (R7-20241219) 2002; 97 (R14-20241219) 1994; 664 (R43-20241219) 2016; 63 (R32-20241219) 1984; 60 (R33-20241219) 2009; 41 (R45-20241219) 1992; 19 (R47-20241219) 2000; 35 (R29-20241219) 2001; 27 (R44-20241219) 1999; 67 (R16-20241219) 1992; 23 (R37-20241219) 1994; 179 (R8-20241219) 1987; 93 (R18-20241219) 2001; 95 31939860 - Anesthesiology. 2020 Feb;132(2):398-399 31939859 - Anesthesiology. 2020 Feb;132(2):398 |
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| Snippet | WHAT WE ALREADY KNOW ABOUT THIS TOPICPreclinical and clinical studies suggest that lidocaine might be neuroprotective, which could benefit surgical patients at... Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest... In a large cohort of non-diabetic cardiac surgical patients, intravenous lidocaine failed to alter cognitive outcomes at 6 weeks after surgery. |
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| SubjectTerms | Administration, Intravenous Aged Anesthetics, Local - administration & dosage Anesthetics, Local - adverse effects Cardiac Surgical Procedures - adverse effects Cardiac Surgical Procedures - trends Double-Blind Method Female Follow-Up Studies Humans Lidocaine - administration & dosage Lidocaine - adverse effects Male Mental Status and Dementia Tests Middle Aged Neurocognitive Disorders - chemically induced Neurocognitive Disorders - diagnosis Neurocognitive Disorders - etiology Postoperative Cognitive Complications - chemically induced Postoperative Cognitive Complications - diagnosis Postoperative Cognitive Complications - etiology Prospective Studies Treatment Outcome |
| Title | Intravenous Lidocaine Does Not Improve Neurologic Outcomes after Cardiac Surgery: A Randomized Controlled Trial |
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