Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial.
Postoperative delirium, arbitrarily defined as occurring within 5 days of surgery, affects up to 50% of patients older than 60 after a major operation. This geriatric syndrome is associated with longer intensive care unit and hospital stay, readmission, persistent cognitive deterioration and mortality. No effective preventive methods have been identified, but preliminary evidence suggests that EEG monitoring during general anaesthesia, by facilitating reduced anaesthetic exposure and EEG suppression, might decrease incident postoperative delirium. This study hypothesises that EEG-guidance of anaesthetic administration prevents postoperative delirium and downstream sequelae, including falls and decreased quality of life.



This is a 1232 patient, block-randomised, double-blinded, comparative effectiveness trial. Patients older than 60, undergoing volatile agent-based general anaesthesia for major surgery, are eligible. Patients are randomised to 1 of 2 anaesthetic approaches. One group receives general anaesthesia with clinicians blinded to EEG monitoring. The other group receives EEG-guidance of anaesthetic agent administration. The outcomes of postoperative delirium (≤5 days), falls at 1 and 12 months and health-related quality of life at 1 and 12 months will be compared between groups. Postoperative delirium is assessed with the confusion assessment method, falls with ProFaNE consensus questions and quality of life with the Veteran's RAND 12-item Health Survey. The intention-to-treat principle will be followed for all analyses. Differences between groups will be presented with 95% CIs and will be considered statistically significant at a two-sided p<0.05.



Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) is approved by the ethics board at Washington University. Recruitment began in January 2015. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.



NCT02241655; Pre-results.
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
T S
TS
Wildes
Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.
A C
AC
Winter
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
H R
HR
Maybrier
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
A M
AM
Mickle
Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.
E J
EJ
Lenze
Department of Occupational Therapy, Washington University Institute for Public Health, School of Medicine, St. Louis, Missouri, USA Department of Neurology, Washington University Institute for Public Health, School of Medicine, St. Louis, Missouri, USA.
S
S
Stark
Department of Mathematics, Biostatistics Division, Washington University in St. Louis, St. Louis, Missouri, USA.
N
N
Lin
Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts, USA.
S K
SK
Inouye
Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts, USA.
E M
EM
Schmitt
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
S L
SL
McKinnon
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
M R
MR
Muench
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
M R
MR
Murphy
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
R T
RT
Upadhyayula
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
B A
BA
Fritz
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
K E
KE
Escallier
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
G P
GP
Apakama
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
D A
DA
Emmert
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
T J
TJ
Graetz
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
T W
TW
Stevens
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
B J
BJ
Palanca
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
R
R
Hueneke
Department of Surgery, Cardiothoracic Division, Washington University School of Medicine, St. Louis, Missouri, USA.
S
S
Melby
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
B
B
Torres
Department of Anesthesia & Perioperative Care, University of California San Francisco, San Francisco, California, USA.
J M
JM
Leung
Department of Anesthesia, University of Manitoba/Winnipeg Regional Health Authority Anesthesia Program, Winnipeg, Manitoba, Canada.
E
E
Jacobsohn
Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA.
M S
MS
Avidan
D000058:Accidental Falls / Q000517:prevention & control / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D000768:Anesthesia, General / Q000009:adverse effects*; D003693:Delirium / Q000453:epidemiology* / Q000517:prevention & control; D004569:Electroencephalography / Q000379:methods*; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control*; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D012044:Regression Analysis; D012107:Research Design; D014481:United States
ANAESTHETICS; EDUCATION & TRAINING (see Medical Education & Training); GERIATRIC MEDICINE