TY - JOUR
T1 - Effect of electroencephalography-guided anesthetic administration on postoperative delirium among older adults undergoing major surgery the engages randomized clinical trial
AU - Wildes, Troy S.
AU - Mickle, Angela M.
AU - Abdallah, Arbi Ben
AU - Maybrier, Hannah R.
AU - Oberhaus, Jordan
AU - Budelier, Thaddeus P.
AU - Kronzer, Alex
AU - McKinnon, Sherry L.
AU - Park, Daniel
AU - Torres, Brian A.
AU - Graetz, Thomas J.
AU - Emmert, Daniel A.
AU - Palanca, Ben J.
AU - Goswami, Shreya
AU - Jordan, Katherine
AU - Lin, Nan
AU - Fritz, Bradley A.
AU - Stevens, Tracey W.
AU - Jacobsohn, Eric
AU - Schmitt, Eva M.
AU - Inouye, Sharon K.
AU - Stark, Susan
AU - Lenze, Eric J.
AU - Avidan, Michael S.
N1 - Funding Information:
Funding/Support: This study was funded by
Funding Information:
a National Institutes of Health grant to support pragmatic trials (1 UH2 HL125141, 5 UH3 AG050312). This study was also funded by the National Institutes of Health NIDUS Grant (NIA R24AG054259) and the Dr Seymour and Rose T. Brown Endowed Chair at Washington University.
Funding Information:
reported grants from National Institute on Aging (NIA) during the conduct of the study and grants from National Institutes of Health (NIH) outside the submitted work. Ms Mickle reported grants from NIA during the conduct of the study. Dr Ben Abdallah reported grants from NIA during the conduct of the study. Ms Maybrier reported grants from NIA during the conduct of the study. Mr Oberhaus reported grants from NIA during the conduct of the study. Dr Budelier reported grants from NIA during the conduct of the study. Mr Kronzer reported grants from the Agency for Healthcare Research and Quality and the National Science Foundation outside the submitted work. Ms McKinnon reported grants from NIA during the conduct of the study and grants from the Agency for Healthcare Research and Quality and the National Science Foundation outside the submitted work. Mr Park reported grants from NIA during the conduct of the study. Dr Palanca reported grants from NIA outside the submitted work during the conduct of the study. Dr Goswami reported grants from the National Science Foundation outside the submitted work. Dr Jordan reports grants from NIA and NIH during the conduct of the study. Dr Lin reported grants from NIA during the conduct of the study. Dr Fritz reported grants from NIH outside the submitted work during the conduct of the study. Dr Jacobsohn reported grants from Canadian Institutes of Health Research outside the submitted work during the conduct of the study. Dr Schmitt reported grants from NIA during the conduct of the study. Dr Inouye reported grants from NIA during the conduct of the study. Dr Stark reported grants from NIA during the conduct of the study. Dr Lenze reported grants from NIA, grants from NIH, grants from FDA and grants from PCORI, personal fees from Takeda, personal fees and nonfinancial support from Alkermes, personal fees from Aptinyx, personal fees and nonfinancial support from Janssen, personal fees from Barnes Jewish Foundation, personal fees from Taylor Family Institute for Innovative Psychiatric Research, personal fees from Lundbeck, and personal fees from McKnight Brain Research Foundation outside the submitted work. Dr Avidan reported grants from NIA and funds from the Dr Seymour and Rose T. Brown Endowed Professorship during the conduct of this study, and grants from other NIH institutes, the Agency for Healthcare Research and Quality, the National Science Foundation, the McDonnell Foundation for Neuroscience, and the Canadian Institutes of Health Research outside the submitted work. No other disclosures were reported.
Funding Information:
Funding for the ENGAGES trial was through a UH2/UH3 mechanism grant awarded by the National Institute on Aging (1UH2AG050312-01 and 4 UH3 AG050312-02). Funding for the SATISFY-SOS study was from a grant awarded by the Barnes-Jewish Hospital Foundation Award Reference Number 7937-77 and support provided by the Department of Anesthesiology at Washington University. In addition, resources for this study and the time of Drs. Inouye and Schmitt were covered in part by grants No.P01AG031720, K07AG041835 and R01AG044518.
Publisher Copyright:
© 2019 American Medical Association.
PY - 2019/2/5
Y1 - 2019/2/5
N2 - IMPORTANCE Intraoperative electroencephalogram (EEG) waveform suppression, often suggesting excessive general anesthesia, has been associated with postoperative delirium. OBJECTIVE To assess whether EEG-guided anesthetic administration decreases the incidence of postoperative delirium. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of 1232 adults aged60years and older undergoing major surgery and receiving general anesthesia at Barnes-Jewish Hospital in St Louis. Recruitmentwas from January 2015 toMay 2018, with follow-up until July 2018. INTERVENTIONS Patients were randomized 1:1 (stratified by cardiac vs noncardiac surgery and positive vs negative recent fall history) to receive EEG-guided anesthetic administration (n = 614) or usual anesthetic care (n = 618). MAIN OUTCOMES AND MEASURES The primary outcomewas incident delirium during postoperative days 1 through 5. Intraoperative measures included anesthetic concentration, EEG suppression, and hypotension. Adverse events included undesirable intraoperative movement, intraoperative awareness with recall, postoperative nausea and vomiting, medical complications, and death. RESULTS Of the 1232 randomized patients (median age, 69 years [range, 60to 95]; 563women [45.7%]), 1213 (98.5%)were assessed for the primary outcome. Delirium during postoperative days 1 to 5 occurred in 157 of 604patients (26.0%)in the guided group and 140 of 609 patients (23.0%)in the usual care group (difference, 3.0%[95%CI, -2.0%to 8.0%]; P = .22). Median end-tidal volatile anesthetic concentrationwas significantly lower in the guided group than the usual care group (0.69 vs0.80minimum alveolar concentration; difference, -0.11 [95%CI, -0.13 to -0.10), and median cumulative time with EEGsuppressionwas significantly less (7 vs 13 minutes; difference, -6.0[95%CI, -9.9 to -2.1]). Therewas no significant difference between groups in the median cumulative time with mean arterial pressure below60mmHg (7 vs 7 minutes; difference,0.0[95%CI, -1.7 to 1.7]). Undesirablemovement occurred in 137 patients (22.3%) in the guided and 95 (15.4%) in the usual care group.Nopatients reported intraoperative awareness. Postoperative nausea and vomitingwas reported in 48 patients (7.8%) in the guided and 55 patients (8.9%) in the usual care group. Serious adverse eventswere reported in 124 patients (20.2%) in the guided and 130 (21.0%)in the usual care group. Within 30 days of surgery, 4 patients (0.65%) in the guided group and 19 (3.07%) in the usual care group died. CONCLUSIONS AND RELEVANCE Among older adults undergoing major surgery, EEG-guided anesthetic administration, compared with usual care, did not decrease the incidence of postoperative delirium. This finding does not support the use of EEG-guided anesthetic administration for this indication.
AB - IMPORTANCE Intraoperative electroencephalogram (EEG) waveform suppression, often suggesting excessive general anesthesia, has been associated with postoperative delirium. OBJECTIVE To assess whether EEG-guided anesthetic administration decreases the incidence of postoperative delirium. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of 1232 adults aged60years and older undergoing major surgery and receiving general anesthesia at Barnes-Jewish Hospital in St Louis. Recruitmentwas from January 2015 toMay 2018, with follow-up until July 2018. INTERVENTIONS Patients were randomized 1:1 (stratified by cardiac vs noncardiac surgery and positive vs negative recent fall history) to receive EEG-guided anesthetic administration (n = 614) or usual anesthetic care (n = 618). MAIN OUTCOMES AND MEASURES The primary outcomewas incident delirium during postoperative days 1 through 5. Intraoperative measures included anesthetic concentration, EEG suppression, and hypotension. Adverse events included undesirable intraoperative movement, intraoperative awareness with recall, postoperative nausea and vomiting, medical complications, and death. RESULTS Of the 1232 randomized patients (median age, 69 years [range, 60to 95]; 563women [45.7%]), 1213 (98.5%)were assessed for the primary outcome. Delirium during postoperative days 1 to 5 occurred in 157 of 604patients (26.0%)in the guided group and 140 of 609 patients (23.0%)in the usual care group (difference, 3.0%[95%CI, -2.0%to 8.0%]; P = .22). Median end-tidal volatile anesthetic concentrationwas significantly lower in the guided group than the usual care group (0.69 vs0.80minimum alveolar concentration; difference, -0.11 [95%CI, -0.13 to -0.10), and median cumulative time with EEGsuppressionwas significantly less (7 vs 13 minutes; difference, -6.0[95%CI, -9.9 to -2.1]). Therewas no significant difference between groups in the median cumulative time with mean arterial pressure below60mmHg (7 vs 7 minutes; difference,0.0[95%CI, -1.7 to 1.7]). Undesirablemovement occurred in 137 patients (22.3%) in the guided and 95 (15.4%) in the usual care group.Nopatients reported intraoperative awareness. Postoperative nausea and vomitingwas reported in 48 patients (7.8%) in the guided and 55 patients (8.9%) in the usual care group. Serious adverse eventswere reported in 124 patients (20.2%) in the guided and 130 (21.0%)in the usual care group. Within 30 days of surgery, 4 patients (0.65%) in the guided group and 19 (3.07%) in the usual care group died. CONCLUSIONS AND RELEVANCE Among older adults undergoing major surgery, EEG-guided anesthetic administration, compared with usual care, did not decrease the incidence of postoperative delirium. This finding does not support the use of EEG-guided anesthetic administration for this indication.
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U2 - 10.1001/jama.2018.22005
DO - 10.1001/jama.2018.22005
M3 - Article
C2 - 30721296
AN - SCOPUS:85061044336
VL - 321
SP - 473
EP - 483
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
SN - 0002-9955
IS - 5
ER -