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Cognitive DeclineNCT00938964

Lidocaine For Neuroprotection During Cardiac Surgery

A study testing Lidocaine in people with Cognitive Decline, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking nerves). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Cognitive Decline
What is being tested?
Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
550 participants
Where
2 sitesUnited States
Study dates
Jul 2009to 23 May 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CABG, CABG + Valve, or Valve surgery
  • Use of cardiopulmonary bypass

Who cannot join

  • Less than 50 years of age
  • History of diabetes
  • History of symptomatic cerebrovascular disease (e.g. prior stroke) with residual deficit
  • Alcoholism (> 2 drinks/day)
  • History of psychiatric illness (any clinical diagnoses requiring therapy)
  • History of drug abuse (any illicit drug use in the past 3 months)
Show all 12Show fewer
  • Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
  • Severe pulmonary insufficiency (requiring home oxygen therapy)
  • Renal failure (baseline serum creatinine > 2.0 mg/dl)
  • Pregnant women
  • Unable to read and thus unable to complete the cognitive testing
  • Score < 24 on a baseline Mini Mental State examination (MMSE) or greater than or equal to 27 on the baseline Center for Epidemiological Studies Depression (CES-D) Scale -

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

Other trials in United States

About this study

The purpose of this study is to see if a drug called lidocaine prevents cognitive injury (a decline in mental abilities) after heart surgery. Lidocaine is currently FDA approved and is commonly used for treating some heart rhythm disorders and for regional anesthesia (blocking nerves). The investigators are enrolling subjects in this research project to see if lidocaine will reduce the high incidence of cognitive injury seen after heart surgery. As part of this study, the investigators will also evaluate the relationship between cognitive injury and genetic makeup and the chemical changes in the subjects blood during and after surgery.

Being tested
Lidocaine, Placebo
Keywords
Cognition
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    Lidocaine versus placebo infusion for 48 hours

  • PlaceboDrug

    Lidocaine versus placebo infusion for 48 hours

Study groups in NCT00938964
Study groupRoleWhat they receive
LidocaineExperimentalLidocaine infusion for 48 hours
Receives: Drug: Lidocaine
PlaceboPlacebo comparatorNormal saline infusion for 48 hours
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change

    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.

    Measured: Preoperative to 6 weeks after surgery

  2. 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

    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.

    Measured: Preoperative to 6 weeks after surgery

Secondary outcomes (27)
  1. Transcerebral Activation Gradients of Platelets

    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

    Measured: Baseline to 6 hours post cross-clamp removal

  2. Transcerebral Activation Gradients of Neutrophils

    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

    Measured: Baseline to 6 hours post cross-clamp removal

  3. Transcerebral Activation Gradients of Monocytes

    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

    Measured: Baseline to 6 hours post cross-clamp removal

  4. Transcerebral Activation Gradient of Platelet-neutrophil Conjugates

    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

    Measured: Baseline to 6 hours post cross-clamp removal

  5. Change in Cognitive Function From Baseline

    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

    Measured: 1 year after surgery

  6. Change in Duke Activity Status Index (DASI)

    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.

    Measured: baseline, 6-weeks

  7. Change in Duke Activity Status Index (DASI)

    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.

    Measured: baseline, 1-year

  8. Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)

    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).

    Measured: baseline, 6-weeks

  9. Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)

    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).

    Measured: baseline, 1-year

  10. Change in Center for Epidemiological Studies Depression Scale (CES-D)

    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.

    Measured: baseline, 6-weeks

  11. Change in Center for Epidemiological Studies Depression Scale (CES-D)

    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.

    Measured: baseline, 1-year

  12. Change in Spielberger State Anxiety Inventory (STAI)

    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.

    Measured: baseline, 6-weeks

  13. Change in Spielberger State Anxiety Inventory (STAI)

    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.

    Measured: baseline, 1-year

  14. Change in Symptom Limitations

    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.

    Measured: baseline, 6-weeks

  15. Change in Symptom Limitations

    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.

    Measured: baseline, 1-year

  16. Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)

    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.

    Measured: baseline, 6-weeks

  17. Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)

    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.

    Measured: baseline, 1-year

  18. Change in the Cognitive Difficulties Scale

    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.

    Measured: baseline, 6-weeks

  19. Change in the Cognitive Difficulties Scale

    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.

    Measured: baseline, 1-year

  20. Change in Perceived Social Support

    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.

    Measured: baseline, 6-weeks

  21. Change in Perceived Social Support

    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.

    Measured: baseline, 1-year

  22. Change in Social Activity

    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.

    Measured: baseline, 6-weeks

  23. Change in Social Activity

    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.

    Measured: baseline, 1-year

  24. Change in Study 36-Item Short Form Health Survey (SF-36)

    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.

    Measured: baseline, 6-weeks

  25. Change in Study 36-Item Short Form Health Survey (SF-36)

    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.

    Measured: baseline, 1-year

  26. Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)

    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.

    Measured: baseline, 6-weeks

  27. Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)

    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.

    Measured: baseline, 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completion18 Jul 2016
  4. Study completion23 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00938964
Sponsor's protocol ID
Pro00015641
Other IDs
R01HL096978
Status last verified
May 2019
First submitted
10 Jul 2009
Last updated
10 May 2019
Data monitoring committee
Yes

Publications

  • Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.

    PubMed 11172175
  • Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. doi: 10.1161/hs1201.099803.

    PubMed 11739990
  • Phillips-Bute B, Mathew JP, Blumenthal JA, Grocott HP, Laskowitz DT, Jones RH, Mark DB, Newman MF. Association of neurocognitive function and quality of life 1 year after coronary artery bypass graft (CABG) surgery. Psychosom Med. 2006 May-Jun;68(3):369-75. doi: 10.1097/01.psy.0000221272.77984.e2.

    PubMed 16738066
  • Mathew JP, Mackensen GB, Phillips-Bute B, Grocott HP, Glower DD, Laskowitz DT, Blumenthal JA, Newman MF; Neurologic Outcome Research Group (NORG) of the Duke Heart Center. Randomized, double-blinded, placebo controlled study of neuroprotection with lidocaine in cardiac surgery. Stroke. 2009 Mar;40(3):880-7. doi: 10.1161/STROKEAHA.108.531236. Epub 2009 Jan 22.

    PubMed 19164788
  • Evans DE, Kobrine AI, LeGrys DC, Bradley ME. Protective effect of lidocaine in acute cerebral ischemia induced by air embolism. J Neurosurg. 1984 Feb;60(2):257-63. doi: 10.3171/jns.1984.60.2.0257.

    PubMed 6693953
  • Mitchell SJ. Lidocaine in the treatment of decompression illness: a review of the literature. Undersea Hyperb Med. 2001 Fall;28(3):165-74.

    PubMed 12067153
  • Astrup J, Sorensen PM, Sorensen HR. Inhibition of cerebral oxygen and glucose consumption in the dog by hypothermia, pentobarbital, and lidocaine. Anesthesiology. 1981 Sep;55(3):263-8. doi: 10.1097/00000542-198109000-00013.

    PubMed 7270951
  • Weber ML, Taylor CP. Damage from oxygen and glucose deprivation in hippocampal slices is prevented by tetrodotoxin, lidocaine and phenytoin without blockade of action potentials. Brain Res. 1994 Nov 21;664(1-2):167-77. doi: 10.1016/0006-8993(94)91967-4.

    PubMed 7895026
  • Ayad M, Verity MA, Rubinstein EH. Lidocaine delays cortical ischemic depolarization: relationship to electrophysiologic recovery and neuropathology. J Neurosurg Anesthesiol. 1994 Apr;6(2):98-110. doi: 10.1097/00008506-199404000-00005.

    PubMed 8012179
  • LoPachin RM, Gaughan CL, Lehning EJ, Weber ML, Taylor CP. Effects of ion channel blockade on the distribution of Na, K, Ca and other elements in oxygen-glucose deprived CA1 hippocampal neurons. Neuroscience. 2001;103(4):971-83. doi: 10.1016/s0306-4522(01)00035-5.

    PubMed 11301205
  • Zhang Y, Lipton P. Cytosolic Ca2+ changes during in vitro ischemia in rat hippocampal slices: major roles for glutamate and Na+-dependent Ca2+ release from mitochondria. J Neurosci. 1999 May 1;19(9):3307-15. doi: 10.1523/JNEUROSCI.19-09-03307.1999.

    PubMed 10212290
  • Fujitani T, Adachi N, Miyazaki H, Liu K, Nakamura Y, Kataoka K, Arai T. Lidocaine protects hippocampal neurons against ischemic damage by preventing increase of extracellular excitatory amino acids: a microdialysis study in Mongolian gerbils. Neurosci Lett. 1994 Sep 26;179(1-2):91-4. doi: 10.1016/0304-3940(94)90942-3.

    PubMed 7845632
  • Diaz L, Gomez A, Bustos G. Lidocaine reduces the hypoxia-induced release of an excitatory amino acid analog from rat striatal slices in superfusion. Prog Neuropsychopharmacol Biol Psychiatry. 1995 Sep;19(5):943-53. doi: 10.1016/0278-5846(95)00122-c.

    PubMed 8539430
  • Dutka AJ, Mink R, McDermott J, Clark JB, Hallenbeck JM. Effect of lidocaine on somatosensory evoked response and cerebral blood flow after canine cerebral air embolism. Stroke. 1992 Oct;23(10):1515-20; discussion 1520-1. doi: 10.1161/01.str.23.10.1515.

    PubMed 1412590
  • Evans DE, Kobrine AI. Reduction of experimental intracranial hypertension by lidocaine. Neurosurgery. 1987 Apr;20(4):542-7. doi: 10.1227/00006123-198704000-00006.

    PubMed 3587544

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine in people with Cognitive Decline, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change (time frame: Preoperative to 6 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00938964, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.

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