NCT02241655

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 18, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

3.3 years

First QC Date

September 11, 2014

Results QC Date

March 6, 2019

Last Update Submit

July 8, 2019

Conditions

Delirium

Keywords

AnesthesiaElectroencephalographyBurst suppressionSurgeryDeliriumFallsHealth related quality of life

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Delirium

    Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five.

    5 days

Secondary Outcomes (2)

  • Postoperative Falls

    Up to 1 year postoperatively

  • Health Related Quality of Life

    Up to one year postoperatively

Other Outcomes (13)

  • Duration of Delirium

    5 days

  • Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions

    5 days

  • Duration or Recurrence of Delirium After Hospital Discharge

    30 days post discharge

  • +10 more other outcomes

Study Arms (2)

EEG guided protocol

EXPERIMENTAL

Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.

Device: a pragmatic EEG-guided anesthetic protocol

Control Arm

NO INTERVENTION

Participants will have the standard anesthetic protocol.

Interventions

a pragmatic EEG-guided anesthetic protocolDEVICE
Also known as: Bispectral Index proprietary processed EEG monitor
EEG guided protocol

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (8)

  • 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.

    PMID: 36130079DERIVED

  • 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.

    PMID: 34243940DERIVED

  • 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.

    PMID: 30721296DERIVED

  • 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.

    PMID: 30621829DERIVED

  • 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.

    PMID: 29550773DERIVED

  • 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.

    PMID: 29239943DERIVED

  • 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.

    PMID: 28698343DERIVED

  • 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.

    PMID: 27311914DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Michael Avidan, MBBCh
Organization
Washington University
avidanm@wustl.edu
314-332-7265

Study Officials

  • Michael S. Avidan, MBBCh, FCASA

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Eric Lenze, MD

    Washington University School of Medicine

    STUDY DIRECTOR

  • Nan Lin, PhD

    Washington University School of Medicine

    STUDY DIRECTOR

  • Susan Stark, PhD

    Washington University School of Medicine

    STUDY DIRECTOR

  • Troy Wildes, MD

    Washington University School of Medicine

    STUDY DIRECTOR

  • Anke Winter, MD

    Washington University School of Medicine

    STUDY DIRECTOR

  • Sharon Inouye, MD

    Hebrew Rehabilitation Center

    STUDY DIRECTOR

  • Arbi Ben Abdallah, PhD

    Washington University School of Medicine

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 16, 2014

Study Start

January 1, 2015

Primary Completion

May 1, 2018

Study Completion

October 1, 2020

Last Updated

July 30, 2019

Results First Posted

June 18, 2019

Record last verified: 2019-07

Locations

US(1)