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Trial record 1 of 1 for:    19164788 [PUBMED-IDS]
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Lidocaine For Neuroprotection During Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00938964
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : August 24, 2017
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Cognitive Decline
Interventions Drug: Lidocaine
Drug: Placebo
Enrollment 550
Recruitment Details 550 participants consented; 478 participants were randomized.
Pre-assignment Details  
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Period Title: Overall Study
Started 241 237
Completed 211 209
Not Completed 30 28
Reason Not Completed
Death             3             3
Lost to Follow-up             2             3
Withdrawal by Subject             22             18
Found to Meet Exclusion Criteria             3             4
Arm/Group Title Lidocaine Placebo Total
Hide Arm/Group Description

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Total of all reporting groups
Overall Number of Baseline Participants 211 209 420
Hide Baseline Analysis Population Description
Number of participants who completed the study are included in the baseline analysis population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 211 participants 209 participants 420 participants
66.9  (9.1) 66.5  (9.5) 66.7  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 209 participants 420 participants
Female
60
  28.4%
49
  23.4%
109
  26.0%
Male
151
  71.6%
160
  76.6%
311
  74.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 211 participants 209 participants 420 participants
211
 100.0%
209
 100.0%
420
 100.0%
1.Primary Outcome
Title Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change
Hide Description To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement.
Time Frame Preoperative to 6 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.07  (0.32) 0.07  (0.37)
2.Primary Outcome
Title Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome
Hide Description To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. Each domain score is normally distributed with a mean of zero. A change score was calculated for each domain by subtracting the baseline from the 6-week score. A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains.
Time Frame Preoperative to 6 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Measure Type: Count of Participants
Unit of Measure: Participants
87
  41.2%
83
  39.7%
3.Secondary Outcome
Title Transcerebral Activation Gradients of Platelets
Hide Description Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
Time Frame Baseline to 6 hours post cross-clamp removal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Planned substudy, that was analyzed after 202 enrolled subjects
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 105 97
Mean (Standard Deviation)
Unit of Measure: Mean linear fluorescence intensity-MLFI
Baseline -0.03  (0.79) 0.35  (1.91)
Cross-clamp removal 0.03  (1.21) 0.43  (1.44)
End of Bypass 0.33  (3.25) 0.05  (2.65)
6 hours post cross-clamp removal 0.37  (2.65) 0.27  (1.07)
4.Secondary Outcome
Title Transcerebral Activation Gradients of Neutrophils
Hide Description Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removal and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
Time Frame Baseline to 6 hours post cross-clamp removal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Planned substudy, that was analyzed after 202 enrolled subjects
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 105 97
Mean (Standard Deviation)
Unit of Measure: Mean linear fluorescence intensity-MLFI
Baseline -2.02  (8.15) -0.08  (9.17)
Cross-clamp removal 0.56  (6.82) 0.17  (5.53)
End of Bypass 0.58  (4.54) 1.19  (6.76)
6 hours post cross-clamp removal 1.04  (7.08) -0.68  (8.61)
5.Secondary Outcome
Title Transcerebral Activation Gradients of Monocytes
Hide Description Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
Time Frame Baseline to 6 hours post cross-clamp removal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Planned substudy, that was analyzed after 202 enrolled subjects.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 105 97
Mean (Standard Deviation)
Unit of Measure: Mean linear fluorescence intensity-MLFI
Baseline -4.22  (19.10) -0.04  (17.78)
Cross-clamp removal -2.46  (16.94) 1.83  (16.80)
End of Bypass -0.34  (19.57) 2.64  (15.69)
6 hours post cross-clamp removal 1.21  (15.08) 0.54  (13.69)
6.Secondary Outcome
Title Transcerebral Activation Gradient of Platelet-neutrophil Conjugates
Hide Description Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups
Time Frame Baseline to 6 hours post cross-clamp removal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Planned substudy, that was analyzed after 202 enrolled subjects.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 105 97
Mean (Standard Deviation)
Unit of Measure: Mean linear fluorescence intensity-MLFI
Baseline -0.15  (9.64) -0.43  (8.40)
Cross-clamp removal 0.02  (4.33) -0.73  (3.97)
End of Bypass -0.73  (4.99) -0.40  (5.12)
6 hours post cross-clamp removal -0.10  (5.40) 0.19  (4.73)
7.Secondary Outcome
Title Change in Cognitive Function From Baseline
Hide Description To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 1 year cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement
Time Frame 1 year after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.09  (0.34) 0.07  (0.34)
8.Secondary Outcome
Title Change in Duke Activity Status Index (DASI)
Hide Description The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done “with no difficulty” receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.
Time Frame baseline, 6-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
-10.98  (15.4) -11.67  (16.8)
9.Secondary Outcome
Title Change in Duke Activity Status Index (DASI)
Hide Description The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done “with no difficulty” receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (18.3) 6.96  (16.9)
10.Secondary Outcome
Title Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)
Hide Description The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Time Frame baseline, 6-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.05  (0.5) 0.04  (0.5)
11.Secondary Outcome
Title Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)
Hide Description The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.05  (0.70) 0.07  (0.60)
12.Secondary Outcome
Title Change in Center for Epidemiological Studies Depression Scale (CES-D)
Hide Description Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as “I had crying spells” and “I felt lonely.” Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.
Time Frame baseline, 6-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.57  (7.5) 0.16  (8.3)
13.Secondary Outcome
Title Change in Center for Epidemiological Studies Depression Scale (CES-D)
Hide Description Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as “I had crying spells” and “I felt lonely.” Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.27  (7.7) -0.89  (7.9)
14.Secondary Outcome
Title Change in Spielberger State Anxiety Inventory (STAI)
Hide Description Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as “I feel nervous” and “I feel worried.” These items are rated on a 4-point scale, based on how well they describe the patient’s current or typical mood, from “not at all” to “very much so.” Scores range from 20 to 80, with higher scores indicating greater anxiety.
Time Frame baseline, 6-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.12  (12.1) -6.31  (11.4)
15.Secondary Outcome
Title Change in Spielberger State Anxiety Inventory (STAI)
Hide Description Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as “I feel nervous” and “I feel worried.” These items are rated on a 4-point scale, based on how well they describe the patient’s current or typical mood, from “not at all” to “very much so.” Scores range from 20 to 80, with higher scores indicating greater anxiety.
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.70  (12.7) -6.39  (10.3)
16.Secondary Outcome
Title Change in Symptom Limitations
Hide Description Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.
Time Frame baseline, 6-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.67  (4.0) -0.8  (3.9)
17.Secondary Outcome
Title Change in Symptom Limitations
Hide Description Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.39  (3.8) -1.48  (3.8)
18.Secondary Outcome
Title Change in the Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL)
Hide Description Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., “Could you prepare your own meals?” “Could you drive a car?”). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.
Time Frame baseline, 6-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.46  (4.2) 2.1  (3.9)
19.Secondary Outcome
Title Change in the Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL)
Hide Description Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., “Could you prepare your own meals?” “Could you drive a car?”). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.15  (2.1) -0.31  (2.6)
20.Secondary Outcome
Title Change in the Cognitive Difficulties Scale
Hide Description Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are “I forget errands I planned to do” and “I fail to recognize people I know.” Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.
Time Frame baseline, 6-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3  (14.6) -3.21  (15.9)
21.Secondary Outcome
Title Change in the Cognitive Difficulties Scale
Hide Description Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are “I forget errands I planned to do” and “I fail to recognize people I know.” Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.46  (16.1) -1.02  (17)
22.Secondary Outcome
Title Change in Perceived Social Support
Hide Description Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is “a special person who is around when I am in need” and “my family really tries to help me.” Choices range from “very strongly disagree” to “very strongly agree.” Items are summed for a range of 12 to 84, with a high score meaning more social support.
Time Frame baseline, 6-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.23  (14) -0.49  (13.9)
23.Secondary Outcome
Title Change in Perceived Social Support
Hide Description Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is “a special person who is around when I am in need” and “my family really tries to help me.” Choices range from “very strongly disagree” to “very strongly agree.” Items are summed for a range of 12 to 84, with a high score meaning more social support.
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.71  (13.4) -1.16  (12.9)
24.Secondary Outcome
Title Change in Social Activity
Hide Description Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are “How often do you talk on the telephone with friends and relatives?” and “How often do you attend meetings of social groups, clubs, or civic organizations?” Scores range from 8 to 32. A lower score indicates more social activity.
Time Frame baseline, 6-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.95  (3.4) 1.59  (3.2)
25.Secondary Outcome
Title Change in Social Activity
Hide Description Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are “How often do you talk on the telephone with friends and relatives?” and “How often do you attend meetings of social groups, clubs, or civic organizations?” Scores range from 8 to 32. A lower score indicates more social activity.
Time Frame baseline, 1-year
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Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.20  (3.2) 0.03  (3.4)
26.Secondary Outcome
Title Change in Study 36-Item Short Form Health Survey (SF-36)
Hide Description The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.
Time Frame baseline, 6-weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
6-Week Change Work activities 2.71  (4.9) 3  (4.3)
6-Week Change General health perception -0.004  (1.3) -0.03  (1.2)
27.Secondary Outcome
Title Change in Study 36-Item Short Form Health Survey (SF-36)
Hide Description The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
1 year Change Work Activities -1.37  (4.3) -1.42  (4.1)
1 year Change General health perception -0.28  (1.2) -0.43  (1.1)
28.Secondary Outcome
Title Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)
Hide Description The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.
Time Frame baseline, 6-weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 211 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.04  (1.10) -0.01  (1.3)
29.Secondary Outcome
Title Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)
Hide Description The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.
Time Frame baseline, 1-year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description:

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

Overall Number of Participants Analyzed 185 192
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.02  (1.10) -0.02  (1.20)
Time Frame Adverse events were collected until hospital discharge (approximately 4 -10 days) . Serious Adverse Events were reported up to one year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lidocaine Placebo
Hide Arm/Group Description

Lidocaine infusion for 48 hours

Lidocaine: Lidocaine versus placebo infusion for 48 hours

Normal saline infusion for 48 hours

Placebo: Lidocaine versus placebo infusion for 48 hours

All-Cause Mortality
Lidocaine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/241 (2.49%)      7/237 (2.95%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lidocaine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   105/241 (43.57%)      103/237 (43.46%)    
Blood and lymphatic system disorders     
Acute Blood Loss anemia   4/241 (1.66%)  4 3/237 (1.27%)  3
Bleeding   6/241 (2.49%)  6 7/237 (2.95%)  7
Chylothorax   0/241 (0.00%)  0 1/237 (0.42%)  1
Coagulopathy   0/241 (0.00%)  0 2/237 (0.84%)  2
Thrombocytopenia   8/241 (3.32%)  8 8/237 (3.38%)  8
Cardiac disorders     
Atrial Dysrhythmia - Atrial Fibrillation   41/241 (17.01%)  41 41/237 (17.30%)  41
Atrial Dysrhythmia -Sinus Bradycardia   0/241 (0.00%)  0 4/237 (1.69%)  4
AV Block   1/241 (0.41%)  1 1/237 (0.42%)  1
Bradycardia   1/241 (0.41%)  1 2/237 (0.84%)  2
Cardiac Arrest   1/241 (0.41%)  1 0/237 (0.00%)  0
Cardiac Tamponade   1/241 (0.41%)  1 0/237 (0.00%)  0
Cardiogenic Shock   0/241 (0.00%)  0 4/237 (1.69%)  4
Complete heart block   7/241 (2.90%)  7 6/237 (2.53%)  6
Congestive Heart Failure   2/241 (0.83%)  2 0/237 (0.00%)  0
Heart attack-hospitalization   0/241 (0.00%)  0 1/237 (0.42%)  1
Heart failure   1/241 (0.41%)  1 2/237 (0.84%)  2
Hemorrhagic shock   2/241 (0.83%)  2 0/237 (0.00%)  0
Hypertension   6/241 (2.49%)  6 2/237 (0.84%)  2
Hypotension   8/241 (3.32%)  8 7/237 (2.95%)  7
Hypovolemic shock   1/241 (0.41%)  1 0/237 (0.00%)  0
Junctional rhythm   5/241 (2.07%)  5 3/237 (1.27%)  3
Left bundle branch block   0/241 (0.00%)  0 1/237 (0.42%)  1
PEA Arrest   1/241 (0.41%)  1 0/237 (0.00%)  0
Pericarditis   0/241 (0.00%)  0 3/237 (1.27%)  3
Pulseless electrical activity   0/241 (0.00%)  0 1/237 (0.42%)  2
Shock   0/241 (0.00%)  0 1/237 (0.42%)  1
Sinus tachycardia   3/241 (1.24%)  3 2/237 (0.84%)  2
Syncope   0/241 (0.00%)  0 1/237 (0.42%)  1
Trifascicular block   0/241 (0.00%)  0 1/237 (0.42%)  1
Ventricular Dysrhythmia - Ventricular Tachycardia   2/241 (0.83%)  2 5/237 (2.11%)  5
Ventricular ectopy   1/241 (0.41%)  1 0/237 (0.00%)  0
Gastrointestinal disorders     
GI Bleed   2/241 (0.83%)  2 0/237 (0.00%)  0
Ileus   2/241 (0.83%)  2 6/237 (2.53%)  6
Irritable bowel syndrome   1/241 (0.41%)  1 0/237 (0.00%)  0
Nausea/Vomiting/Constipation   0/241 (0.00%)  0 4/237 (1.69%)  4
General disorders     
Fluid overload   1/241 (0.41%)  1 1/237 (0.42%)  1
Pain   1/241 (0.41%)  1 1/237 (0.42%)  1
Prolonged hospitalization   1/241 (0.41%)  1 0/237 (0.00%)  0
re-admission after fall   2/241 (0.83%)  2 0/237 (0.00%)  0
Immune system disorders     
Anaphylatic or Anaphylactoid rxn   1/241 (0.41%)  1 0/237 (0.00%)  0
Fever of Non-Specified Origin   0/241 (0.00%)  0 1/237 (0.42%)  1
Phlebitis   1/241 (0.41%)  1 1/237 (0.42%)  1
Tranfusion rxn   0/241 (0.00%)  0 1/237 (0.42%)  1
Infections and infestations     
Bacermia/sepsis   1/241 (0.41%)  1 0/237 (0.00%)  0
Haemophilus Influenzae   1/241 (0.41%)  1 0/237 (0.00%)  0
Infection   2/241 (0.83%)  2 0/237 (0.00%)  0
Leukocytosis   8/241 (3.32%)  8 7/237 (2.95%)  7
MRSA   2/241 (0.83%)  2 0/237 (0.00%)  0
Sternal Wound Infection   1/241 (0.41%)  1 0/237 (0.00%)  0
Thrush   0/241 (0.00%)  0 1/237 (0.42%)  1
Ventilator associated pneumonia   1/241 (0.41%)  1 0/237 (0.00%)  0
Injury, poisoning and procedural complications     
Diaphragmic tear   1/241 (0.41%)  1 0/237 (0.00%)  0
Pulmonary contusion   3/241 (1.24%)  3 0/237 (0.00%)  0
Metabolism and nutrition disorders     
Hyperkalemia   1/241 (0.41%)  1 0/237 (0.00%)  0
Hypokalemia   1/241 (0.41%)  1 0/237 (0.00%)  0
Hyponatremia   1/241 (0.41%)  1 2/237 (0.84%)  2
Lactic acidosis   1/241 (0.41%)  1 0/237 (0.00%)  0
Metabolic acidosis   0/241 (0.00%)  0 1/237 (0.42%)  1
Protein malnutrition   0/241 (0.00%)  0 1/237 (0.42%)  1
Nervous system disorders     
Aphasia   0/241 (0.00%)  0 1/237 (0.42%)  1
Confusion/encephalopathy   0/241 (0.00%)  0 1/237 (0.42%)  1
Continuous coma   1/241 (0.41%)  1 0/237 (0.00%)  0
Dysphagia   1/241 (0.41%)  1 1/237 (0.42%)  1
Hypothermia   0/241 (0.00%)  0 1/237 (0.42%)  1
Left vocal cord palsy   0/241 (0.00%)  0 1/237 (0.42%)  1
Parkinson's disease   0/241 (0.00%)  0 1/237 (0.42%)  1
Renal and urinary disorders     
Acute Urinary Retention   0/241 (0.00%)  0 1/237 (0.42%)  1
Acute Kidney Injury   2/241 (0.83%)  2 6/237 (2.53%)  6
Hematuria   1/241 (0.41%)  1 0/237 (0.00%)  0
Renal Failure   1/241 (0.41%)  1 1/237 (0.42%)  1
Renal Insufficiency   7/241 (2.90%)  7 5/237 (2.11%)  5
Urinary Tract Infection   3/241 (1.24%)  3 1/237 (0.42%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchitis   0/241 (0.00%)  0 1/237 (0.42%)  1
Hemoptysis   0/241 (0.00%)  0 1/237 (0.42%)  1
Hemothorax   2/241 (0.83%)  2 0/237 (0.00%)  0
Hypoxemia   3/241 (1.24%)  3 1/237 (0.42%)  1
Pleural Effusion   5/241 (2.07%)  5 6/237 (2.53%)  6
Pneumonia   2/241 (0.83%)  2 2/237 (0.84%)  2
Pneumothorax   1/241 (0.41%)  1 1/237 (0.42%)  1
Pulmonary congestion   0/241 (0.00%)  0 1/237 (0.42%)  1
Pulmonary Edema   2/241 (0.83%)  2 5/237 (2.11%)  5
Respiratory Distress   1/241 (0.41%)  1 2/237 (0.84%)  2
Respiratory Failure   4/241 (1.66%)  4 6/237 (2.53%)  6
Subcutaneous Air   1/241 (0.41%)  1 0/237 (0.00%)  0
Ventilation > 48hr   1/241 (0.41%)  1 0/237 (0.00%)  0
Surgical and medical procedures     
Left brachial embolectomy   1/241 (0.41%)  1 0/237 (0.00%)  0
Left pleural effusion thoracentesis   0/241 (0.00%)  0 1/237 (0.42%)  1
LVAD   0/241 (0.00%)  0 1/237 (0.42%)  1
Pacemaker Placement   6/241 (2.49%)  6 8/237 (3.38%)  8
Reexploration For Bleeding   4/241 (1.66%)  4 4/237 (1.69%)  4
Reintubation   0/241 (0.00%)  0 1/237 (0.42%)  1
Suprapubic catheter placement   0/241 (0.00%)  0 1/237 (0.42%)  1
Thoracentesis   0/241 (0.00%)  0 2/237 (0.84%)  2
Vascular disorders     
Deep Vein Thrombosis   0/241 (0.00%)  0 2/237 (0.84%)  2
Stroke   2/241 (0.83%)  2 6/237 (2.53%)  6
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lidocaine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/241 (14.11%)      34/237 (14.35%)    
Cardiac disorders     
Atrial Dysrhythmia - Atrial Fibrillation   34/241 (14.11%)  34 34/237 (14.35%)  34
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joseph Mathew, M.D
Organization: Duke University Health System
Phone: 919-681-6646
Publications:
Rey A. L'examen clinique en psychologie. Paper presented at : Presses Universitaires de France, 1964; Paris
Randt C, Brown E. Administration Manual: Randt Memory Test. New Youk Life Sciences Associates; 1983
Wechsler D. The Wechsler Adult Intelligence Sacle-Revised (Manual): Psychological Corporation: 1981.
Reitan RM. Validity of the trail making test as an indicator of organic brain damage. Percept Mot Skills, 1958; 8:271-276
Mark DB, Nelson C, Delong E, et al. Comparisin of quality of life outcomes following coronary angioplasty, coronary bypass surgery and medicine. J Am Coll Cardiol. 1993; 21:216A
McDowell I, Newell C. Measuring Health: A Guide To Rating Scales And Questionnaires. New York: Oxford University Press; 1987.
Cronbach LJ. Essentials of Psycological Testing. New York: Harper and Row; 1970
Benjamini Y, Hochberg Y. Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing. J R Statist Soc B. 1995;57(1):289-300
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00938964     History of Changes
Other Study ID Numbers: Pro00015641
R01HL096978 ( U.S. NIH Grant/Contract )
First Submitted: July 10, 2009
First Posted: July 14, 2009
Results First Submitted: July 18, 2017
Results First Posted: August 24, 2017
Last Update Posted: June 21, 2018