Anesthetic Depth and Postoperative Delirium Trial - 2 (ADAPT2)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Delirium; Cognitive Disorders

Treatments: Other: Processed EEG-guided anesthetic depth

Study type: Interventional

Funder types: Other

Identifiers

NCT01983384

ANESDEPTH

Details and patient eligibility

About

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

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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205 participants in 2 patient groups, including a placebo group

Anesthetic Depth: standard care

Placebo Comparator group

Description:

A cohort of older patients undergoing major non-cardiac surgery will be randomized to receive routine anesthetic management not guided by the processed electroencephalogram

Treatment:

Other: Processed EEG-guided anesthetic depth

Anesthetic Depth: interventional

Experimental group

Description:

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)

Treatment:

Other: Processed EEG-guided anesthetic depth