Clinical trial NCT02241655: Electroencephalography Guidance of Anesthesia
Official title: Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Keywords: Anesthesia
Electroencephalography
Burst suppression
Surgery
Delirium
Falls
Health related quality of life
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-09-16
Enrollment: 1400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to determine whether, compared with usual anesthetic care, an electroencephalography-guided anesthesia protocol is effective at preventing postoperative delirium and its downstream effects, and improving postoperative patient reported health-related quality of life.

Detailed description: Delirium is one of several geriatric syndromes, and is among the most common postoperative complications, affecting up to 70% of surgical patients older than 60. Delirium is an acute change that manifests as inattention and inability to think logically, and is deeply distressing to patients and their families. Based on our surveys of 1,000 surgical patients, over 30% were worried about experiencing delirium. Delirious patients are unable to participate effectively in rehabilitation exercises and are susceptible to other geriatric syndromes, like falls. The occurrence and duration of delirium are associated with longer intensive care unit and hospital stay, persistent cognitive deterioration, hospital readmission and increased mortality rate. Additionally, delirium carries a huge social and economic burden, costing over $60,000 per patient per year. Despite the importance of delirium to patients and to society, no approach has been proven to prevent postoperative delirium. Furthermore postoperative delirium is frequently unrecognized, and surgical patients are not followed systematically after they are discharged from hospital. Without diagnosing delirium or following patients postoperatively, we are limited in our ability to test the effectiveness of any intervention to prevent or treat postoperative delirium and its sequelae. There is mounting evidence that electroencephalography guidance of general anesthesia can decrease postoperative delirium. Specifically, our group has found that a suppressed electroencephalogram pattern, which occurs with deep anesthesia, is associated with increased delirium and death after surgery. The Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study will therefore compare the effectiveness of two anesthetic protocols for reduction of postoperative delirium. One protocol will be based on current standard anesthetic practice, and the other protocol will be based on electroencephalography guidance. We also expect to determine the impact of the anesthetic protocols on patient reported outcomes of health-related quality of life. At Washington University, we have successfully implemented an ambitious study that enrolls patients at the preoperative assessment clinic, and tracks their health and wellbeing at 30 days and at 1-year postoperatively. This will enable us to assess the consequences of postoperative delirium and to determine whether anesthetic management can impact patient reported outcomes, such as health-related quality of life. We shall also explore whether a multi-component safety intervention for delirious patients prevents downstream adverse events, like falls. The ENGAGES study - through its structured anesthesia protocols, its thorough approach to delirium assessment, and its ability to track patients' health and wellbeing postoperatively - is poised to make a major contribution to the care of elderly patients who are at risk of postoperative delirium and other adverse outcomes.

Eligibility criteria: Inclusion:

* Patients 60 years old and older,
* Competent to provide informed consent
* Undergoing major elective surgery that requires a minimum stay of 2 days postoperatively (e.g., open cardiac surgery, open thoracic surgery, major vascular surgery, intra-abdominal surgery, open gynecologic surgery, open urologic surgery, major orthopedic surgery, open hepato-biliary surgery and major ear, nose and throat surgery)

Exclusions

* Neurosurgical procedures will be excluded as surgery on the brain can confound the outcome (postoperative delirium).
* Patients with preoperative delirium and patients who are unable to participate adequately in delirium screening including those who are blind, deaf, or illiterate or fluent in languages other than English.

Primary outcomes:
measure: Number of Participants With Delirium
timeFrame: 5 days
Secondary outcomes:
measure: Postoperative Falls
timeFrame: Up to 1 year postoperatively
measure: Health Related Quality of Life
timeFrame: Up to one year postoperatively
Other outcomes:
measure: Duration of Delirium
timeFrame: 5 days
measure: Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions
timeFrame: 5 days
measure: Duration or Recurrence of Delirium After Hospital Discharge
timeFrame: 30 days post discharge
measure: Clinically Relevant Outcomes Associated With Delirium
timeFrame: 1 year
measure: Comparison of Patient-reported and Observational Pain Scores
timeFrame: 5 days
measure: Postoperative Actigraphy
timeFrame: 1 day
measure: Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments
timeFrame: 5 days
measure: Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth
timeFrame: 1 year
measure: Delirium Prediction Models
timeFrame: 5 days
measure: Collaborations With Other Studies
timeFrame: 5 years
measure: Number of Participants With Severe Delirium
timeFrame: 5 days
measure: EEG and Delirium
timeFrame: 5 days
measure: Postoperative Actigraphy- Immobile Minutes
timeFrame: 1 day
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael S. Avidan, MBBCh, FCASA
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Eric Lenze, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Nan Lin, PhD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Susan Stark, PhD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Troy Wildes, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Anke Winter, MD
role: STUDY_DIRECTOR
affiliation: Hebrew Rehabilitation Center
name: Sharon Inouye, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Arbi Ben Abdallah, PhD
role: STUDY_DIRECTOR
References:
citation: Guay CS, Kafashan M, Huels ER, Jiang Y, Beyoglu B, Spencer JW, Geczi K, Apakama G, Ju YS, Wildes TS, Avidan MS, Palanca BJA. Postoperative Delirium Severity and Recovery Correlate With Electroencephalogram Spectral Features. Anesth Analg. 2023 Jan 1;136(1):140-151. doi: 10.1213/ANE.0000000000006075. Epub 2022 May 13.
citation: Fritz BA, King CR, Mickle AM, Wildes TS, Budelier TP, Oberhaus J, Park D, Maybrier HR, Ben Abdallah A, Kronzer A, McKinnon SL, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Stevens TW, Stark SL, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of electroencephalogram-guided anaesthesia administration on 1-yr mortality: follow-up of a randomised clinical trial. Br J Anaesth. 2021 Sep;127(3):386-395. doi: 10.1016/j.bja.2021.04.036. Epub 2021 Jul 7.
citation: Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
citation: Maybrier HR, King CR, Crawford AE, Mickle AM, Emmert DA, Wildes TS, Avidan MS, Palanca BJA; ENGAGES Study Investigators. Early Postoperative Actigraphy Poorly Predicts Hypoactive Delirium. J Clin Sleep Med. 2019 Jan 15;15(1):79-87. doi: 10.5664/jcsm.7576.
citation: Aranake-Chrisinger A, Cheng JZ, Muench MR, Tang R, Mickle A, Maybrier H, Lin N, Wildes T, Lenze E, Avidan MS. Ability of postoperative delirium to predict intermediate-term postoperative cognitive function in patients undergoing elective surgery at an academic medical centre: protocol for a prospective cohort study. BMJ Open. 2018 Mar 17;8(3):e017079. doi: 10.1136/bmjopen-2017-017079.
citation: Mickle AM, Maybrier HR, Winter AC, McKinnon SL, Torres BA, Lin N, Lenze EJ, Stark S, Muench MR, Jacobsohn E, Inouye SK, Avidan MS, Wildes TS; ENGAGES Research Group*. Achieving Milestones as a Prerequisite for Proceeding With a Clinical Trial. Anesth Analg. 2018 Jun;126(6):1851-1858. doi: 10.1213/ANE.0000000000002680.
citation: Cui V, Tedeschi CM, Kronzer VL, McKinnon SL, Avidan MS. Protocol for an observational study of delirium in the post-anaesthesia care unit (PACU) as a potential predictor of subsequent postoperative delirium. BMJ Open. 2017 Jul 10;7(7):e016402. doi: 10.1136/bmjopen-2017-016402.
citation: Wildes TS, Winter AC, Maybrier HR, Mickle AM, Lenze EJ, Stark S, Lin N, Inouye SK, Schmitt EM, McKinnon SL, Muench MR, Murphy MR, Upadhyayula RT, Fritz BA, Escallier KE, Apakama GP, Emmert DA, Graetz TJ, Stevens TW, Palanca BJ, Hueneke R, Melby S, Torres B, Leung JM, Jacobsohn E, Avidan MS. Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial. BMJ Open. 2016 Jun 15;6(6):e011505. doi: 10.1136/bmjopen-2016-011505.