Anesthetic Depth and Postoperative Delirium Trial - 2

Not Applicable

Completed

• Conditions: Cognitive Disorders; Delirium
• Interventions: Other: Processed EEG-guided anesthetic depth

• Registration Number: NCT01983384
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-14
• Study Start: 2015-07
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anesthetic Depth: interventional	Processed EEG-guided anesthetic depth	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)
Anesthetic Depth: standard care	Processed EEG-guided anesthetic depth	A cohort of older patients undergoing major non-cardiac surgery will be randomized to receive routine anesthetic management not guided by the processed electroencephalogram

Primary Outcome Measures

Name	Time	Method
Intraoperative EEG Suppression	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

Name	Time	Method
Patient intraoperative awareness and recall	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.
Anesthesiologists' adherence to assigned processed EEG index in the interventional group	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?")
Intraoperative systolic and diastolic blood pressure	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
Postoperative delirium	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
Patient movement	During surgery	Patient movement will be recorded from the anesthesia record
Preoperative level of cognitive function	Up to one week before surgery	Level of cognitive function will be measured by Telephone Interview for Cognitive Status
Intraoperative heart rate	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

Trial Locations

Locations (1)

University of California, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States