Delirium Clinical Trial
Official title:
A Randomised Controlled Trial to Reduce Postoperative Delirium Through Reduction in Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery
Recent limited evidence suggests that anesthetic depth may influence postoperative cognitive outcomes, however, the mechanism between this association is unclear.
Recently, it has been proposed that use of a processed electroencephalogram (EEG) monitor
during surgery may be associated with a lower rate of postoperative delirium. In fact, some
suggest that older patients undergoing surgery should routinely be monitored with an
anesthetic depth monitor to allow the titration of anesthetics or sedation medications to
lighter levels to promote better postoperative cognitive outcomes. Recent studies, including
preliminary results from our group, have demonstrated electroencephalogram (EEG) suppression
to be an independent risk factor for postoperative delirium.
Prior studies that have focused on risk prediction have shown age and prior cognitive
impairment to be the most consistent risk factors for postoperative delirium. However, as of
yet, no clinical trial has identified a relationship whether use of processed EEG monitor
resulted in a reduction of incident postoperative delirium through a reduction in EEG
suppression, with proper consideration of patients' baseline cognitive status as a potential
moderator. Additionally, use of anesthetic depth monitor to keep patients' anesthetic depth
above a specified value has never been validated or proven to be feasible or safe.
Accordingly, the investigators plan an exploratory study to: 1) determine whether the use of
processed EEG to keep anesthetic depth above a specified level, results in a reduction in EEG
suppression when compared to standard anesthetic care, 2) to determine whether preoperative
level of cognitive function moderates the effect of group assignment on EEG suppression, and
3) to determine the feasibility and safety of using processed EEG-guided to keep patients'
anesthetic depth above a specified value. A secondary aim was to determine the effect size
for the intervention to reduce postoperative delirium for subjects with and without
preoperative cognitive impairment for a future trial.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
| Recruiting |
NCT05891873 -
Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
|
||
| Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
| Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
| Recruiting |
NCT06194474 -
Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
|
||
| Completed |
NCT03095417 -
Improving the Recovery and Outcome Every Day After the ICU
|
N/A | |
| Completed |
NCT05395559 -
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
|
||
| Terminated |
NCT03337282 -
Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
|
||
| Not yet recruiting |
NCT04846023 -
Pediatric Delirium Screening in the PICU Via EEG
|
N/A | |
| Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
| Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
| Withdrawn |
NCT02673450 -
PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
|
||
| Recruiting |
NCT03256500 -
Transcranial Direct Current Stimulation for the Treatment of Delirium
|
N/A | |
| Completed |
NCT02890927 -
Geriatric-CO-mAnagement for Cardiology Patients in the Hospital
|
N/A | |
| Not yet recruiting |
NCT02892968 -
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
|
N/A | |
| Recruiting |
NCT03165539 -
Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
|
||
| Completed |
NCT02554253 -
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
|
Phase 2 | |
| Completed |
NCT02518646 -
DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models
|
N/A | |
| Recruiting |
NCT02305589 -
The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium
|
N/A | |
| Completed |
NCT02628925 -
Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale
|
N/A |