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Completed

NCT Number: NCT01983384

Anesthetic Depth and Postoperative Delirium Trial - 2

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

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Key information

Conditions

Delirium Cognition Disorders Cognitive Disorders Cognitive Dysfunction Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco Medical Center

San Francisco, California, 94143-0648, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Processed EEG-guided anesthetic depth

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Virginia Polytechnic Institute and State University

Registry information

Official study title

A Randomised Controlled Trial to Reduce Postoperative Delirium Through Reduction in Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery

Acronym: ADAPT2

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 14, 2013
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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