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Anesthetic Depth and Postoperative Delirium Trial - 2 (ADAPT2)

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ClinicalTrials.gov Identifier: NCT01983384
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Recent limited evidence suggests that anesthetic depth may influence postoperative cognitive outcomes, however, the mechanism between this association is unclear.

Condition or disease Intervention/treatment Phase
Delirium Cognitive Disorders Other: Processed EEG-guided anesthetic depth Not Applicable

Detailed Description:

Recently, it has been proposed that use of a processed electroencephalogram (EEG) monitor during surgery may be associated with a lower rate of postoperative delirium. In fact, some suggest that older patients undergoing surgery should routinely be monitored with an anesthetic depth monitor to allow the titration of anesthetics or sedation medications to lighter levels to promote better postoperative cognitive outcomes. Recent studies, including preliminary results from our group, have demonstrated electroencephalogram (EEG) suppression to be an independent risk factor for postoperative delirium.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be assigned to receive processed EEG-guided anesthesia or standard anesthetic care. Patients in both groups will be monitored with processed EEG, however those in the standard care group will have the anesthesiologist blinded to the machine. Patients in the interventional group receive processed EEG-guided anesthetic maintenance.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients are assigned to study arm by random number generator. Anesthesiologists are informed which study arm the patient is assigned before the day of surgery. Patients are not informed of study arm assignment. Research staff assessing for postoperative delirium are not informed of patient study arm assignment.
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial to Reduce Postoperative Delirium Through Reduction in Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery
Actual Study Start Date : July 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Placebo Comparator: 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
Other: 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

Experimental: 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)
Other: 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




Primary Outcome Measures :
  1. Intraoperative EEG Suppression [ Time Frame: Patients will be monitored by processed EEG intraoperatively, for the duration of surgery ]
    Intraoperative EEG suppression will be measured by processed EEG monitor


Secondary Outcome Measures :
  1. Preoperative level of cognitive function [ Time Frame: Up to one week before surgery ]
    Level of cognitive function will be measured by Telephone Interview for Cognitive Status

  2. Patient intraoperative awareness and recall [ Time Frame: Intraoperative recall and awareness will be measured within 72 hours after end of surgery ]
    Intraoperative recall and awareness measured using modified Brice questionnaire (2 question survey - each answered with a yes or no, with additional checkboxes for applicable descriptions of events recalled [e.g. "Hearing voices," "Feeling pain," etc]) Patients answering yes to either question are classified as accidental awareness after general anesthesia (AAGA), which is regarded as an intraoperative adverse event.

  3. Patient movement [ Time Frame: During surgery ]
    Patient movement will be recorded from the anesthesia record

  4. Intraoperative systolic and diastolic blood pressure [ Time Frame: During surgery ]
    Intraoperative systolic and diastolic blood pressure will be continuously downloaded onto a computer for subsequent analysis. Increases or decreases above the preoperative baseline measurements will be measured and recorded from the medical record

  5. Intraoperative heart rate [ Time Frame: During surgery ]
    Intraoperative heart rate will be continuously downloaded onto a computer for subsequent analysis. Increases or decreases above the preoperative baseline measurements will be measured and recorded from the medical record

  6. Anesthesiologists' adherence to assigned processed EEG index in the interventional group [ Time Frame: Anesthesiologists complete self-report within 72 hours after end of surgery. This outcome measure is collected once for each patient through study completion, an average of 2 years. ]
    Anesthesiologists' assigned to patients randomized to the interventional group were given a short self-report survey at the end of each surgery (e.g. "Did the PSI go below the PSI threshold of 35 at any point during surgery?")

  7. Postoperative delirium [ Time Frame: Daily for three postoperative days. ]
    Research staff, blinded to group assignment, will assess for delirium using the Confusion Assessment Method, a physician-validated screening tool for hospital delirium



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65 years and older of age undergoing non-cardiac surgery, requiring hospital stay of 2 or more days.

Exclusion Criteria:

  • patients who are not fluent in English or cannot provide informed consent
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983384


Locations
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United States, California
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143-0648
Sponsors and Collaborators
University of California, San Francisco
Virginia Polytechnic Institute and State University
Investigators
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Principal Investigator: Jacqueline Leung, MD, MPH University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01983384    
Other Study ID Numbers: ANESDEPTH
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Delirium
Cognition
Surgery
Anesthesia
Aging
Electroencephalography
Additional relevant MeSH terms:
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Delirium
Cognition Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs