Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
205 participants
INTERVENTIONAL
2015-07-31
2017-10-31
Brief Summary
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Detailed Description
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Prior studies that have focused on risk prediction have shown age and prior cognitive impairment to be the most consistent risk factors for postoperative delirium. However, as of yet, no clinical trial has identified a relationship whether use of processed EEG monitor resulted in a reduction of incident postoperative delirium through a reduction in EEG suppression, with proper consideration of patients' baseline cognitive status as a potential moderator. Additionally, use of anesthetic depth monitor to keep patients' anesthetic depth above a specified value has never been validated or proven to be feasible or safe.
Accordingly, the investigators plan an exploratory study to: 1) determine whether the use of processed EEG to keep anesthetic depth above a specified level, results in a reduction in EEG suppression when compared to standard anesthetic care, 2) to determine whether preoperative level of cognitive function moderates the effect of group assignment on EEG suppression, and 3) to determine the feasibility and safety of using processed EEG-guided to keep patients' anesthetic depth above a specified value. A secondary aim was to determine the effect size for the intervention to reduce postoperative delirium for subjects with and without preoperative cognitive impairment for a future trial.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Anesthetic Depth: standard care
A cohort of older patients undergoing major non-cardiac surgery will be randomized to receive routine anesthetic management not guided by the processed electroencephalogram
Processed EEG-guided anesthetic depth
Investigators will undertake a randomized control trial in a cohort of older patients undergoing major non-cardiac surgery to receive either a control vs. an intervention of anesthesia as determined by a processed electroencephalogram
Anesthetic Depth: interventional
A cohort of older patients undergoing major non-cardiac surgery will be randomized to receive anesthetic management guided by the processed electroencephalogram (processed EEG-guided anesthetic depth)
Processed EEG-guided anesthetic depth
Investigators will undertake a randomized control trial in a cohort of older patients undergoing major non-cardiac surgery to receive either a control vs. an intervention of anesthesia as determined by a processed electroencephalogram
Interventions
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Processed EEG-guided anesthetic depth
Investigators will undertake a randomized control trial in a cohort of older patients undergoing major non-cardiac surgery to receive either a control vs. an intervention of anesthesia as determined by a processed electroencephalogram
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients who may not tolerate either light or deep anesthesia (history of heart failure, coronary artery disease, substance abuse)
* history of intraoperative recall or awareness during anesthesia
* pathologies of the brain which may affect EEG monitoring
* patients who are anticipated to have consecutive surgery within 3 days of first procedure
* patients who have had surgery with general anesthesia in the past 30 days
65 Years
ALL
Yes
Sponsors
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Virginia Polytechnic Institute and State University
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Jacqueline Leung, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco Medical Center
San Francisco, California, United States
Countries
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References
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Tang CJ, Jin Z, Sands LP, Pleasants D, Tabatabai S, Hong Y, Leung JM. ADAPT-2: A Randomized Clinical Trial to Reduce Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery. Anesth Analg. 2020 Oct;131(4):1228-1236. doi: 10.1213/ANE.0000000000004713.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ANESDEPTH
Identifier Type: -
Identifier Source: org_study_id