Anesthetic Depth and Postoperative Delirium Trial - 2

NCT01983384 | Completed DMC

• 1 other identifier: ANESDEPTH
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Delirium; Cognitive Disorders

Keywords

Delirium; Cognition; Surgery; Anesthesia; Aging; Electroencephalography

Outcome Measures

Primary Outcomes (1)

• Intraoperative EEG Suppression

  Intraoperative EEG suppression will be measured by processed EEG monitor

  Patients will be monitored by processed EEG intraoperatively, for the duration of surgery

Secondary Outcomes (7)

• Preoperative level of cognitive function

  Up to one week before surgery

• Patient intraoperative awareness and recall

  Intraoperative recall and awareness will be measured within 72 hours after end of surgery

• Patient movement

  During surgery

• Intraoperative systolic and diastolic blood pressure

  During surgery

• Intraoperative heart rate

  During surgery

Study Arms (2)

Anesthetic Depth: standard care

PLACEBO COMPARATOR

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

Anesthetic Depth: interventional

EXPERIMENTAL

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

Interventions

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

Anesthetic Depth: interventional; Anesthetic Depth: standard care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

University of California, San Francisco Medical Center

San Francisco, California, 94143-0648, United States

Location

Related Publications (1)

• 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.

  PMID: 32925344 DERIVED

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Jacqueline Leung, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 14, 2013
• Study Start: July 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)