Neurocognitive Disorders After Major Surgery in Elderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorCiusss de L'Est de l'Île de Montréal
About this trial
The objective of the study is to investigate, in patients aged 70 years and over undergoing major non-cardiac surgery, the effect of electroencephalic (EEG)-guided anesthesia on postoperative neurocognitive disorders when controlling for intraoperative nociception, personalized blood pressure targets and using full information provided by the processed EEG monitor (including burst suppression ratio, density spectral array and raw EEG waveform).
This prospective, randomized, controlled trial will be conducted in a single Canadian university hospital. Patients aged 70 years and over, undergoing elective major non-cardiac surgery will be included. The administration of sevoflurane will be adjusted to maintain a BIS value between 40 and 60, a suppression Ratio at 0%, a direct EEG display without any suppression time and a spectrogram with most of the EEG wave frequency within the alpha, theta and delta frequencies in the EEG-guided group. In the control group sevoflurane will be administered to achieve an age-adjusted minimum alveolar concentration of \[0.8-1.2\]. A nociception monitor will guide intraoperative opioids' infusion and individual blood pressure targets will be personalized in both groups. The primary endpoint is the incidence of neurocognitive disorder (NCD) at postoperative day 1 evaluated by the Montréal Cognitive Assessment. Secondary endpoints include the incidence of postoperative neurocognitive disorder at different timepoints and the evaluation of cognitive trajectories among EEG-guided and control groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 70 years of age or older,
Major gynecologic, abdominal, urologic, thoracic or orthopedic surgery via laparoscopy or laparotomy under general anesthesia - with or without concomitant use of regional or neuraxial anesthesia -,
Expected anesthesia time of more than 60 minutes,
Seen for assessment by internal medicine and/or anesthesiology at the preoperative clinic (CIEPC)
Disqualifiers
Known diagnosis of dementia or other neurological, psychiatric, developmental or medical condition that resulted in documented severe cognitive impairment,
Emergency surgery,
Significant auditory or visual impairment that precludes participation in cognitive testing,
Known allergy or intolerance or other medical condition that precludes the use of prescribed general anesthesia protocol for this study,
Trial design
Design model
Parallel
Treatments tested in this trial
BIS monitor
DeviceInformation provided by the BIS (Medtronic, Canada) monitor will guide the volatile anesthetic administration in the EEG-guided group to maintain a BIS value between 40 and 60, a Suppression Ratio (SR; % of time with suppressed brain electrical activity) at 0% or the closest, a direct EEG display without any suppression time and a spectrogram (DSA or density spectral array) with most of the EEG wave frequency within the Alpha (8-12Hz), Theta (4-8Hz) and Delta (0.5-4Hz) frequencies.
Control group
Other interventionIn the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at \[0.8-1.2\] MAC.
Treatment groups
314 Participants
are divided into 2 treatment groupsGroup A: Electroencephalographic (EEG)-guided groupActive comparator 1 intervention
Group B: Standard Care (SC) groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result.
The presence of postoperative neurocognitive disorder will be evaluated using the Montreal Cognitive Assessment The Montréal Cognitive Assessment range from 0 to 30, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the Montréal Cognitive assessment will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Baseline cognitive testing will be performed before surgery, then repeated on postoperative day 1 (primary endpoint)
Time frame
Postoperative day 1Secondary outcomes
1
Postoperative neurocognitive disorder day 2 (Yes/No); dichotomic result.
The presence of postoperative neurocognitive disorder will be evaluated using the Montreal Cognitive Assessment (MoCA) The Montréal Cognitive Assessment range from 0 to 30, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the Montréal Cognitive assessment will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Baseline cognitive testing will be performed before surgery, then repeated on postoperative day 2
Time frame
Postoperative day 22
Postoperative neurocognitive disorder day 7 (Yes/No); dichotomic result.
The presence of postoperative neurocognitive disorder will be evaluated using the Telephone Montreal Cognitive Assessment (T-MoCA) The Telephone MoCA range from 0 to 22, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the Montréal Cognitive assessment will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Baseline cognitive testing will be performed before surgery, then repeated on postoperative day 7
Time frame
Postoperative day 73
Postoperative neurocognitive disorder day 15 (Yes/No); dichotomic result.
The presence of postoperative neurocognitive disorder will be evaluated using the Telephone Montreal Cognitive Assessment (T-MoCA) The Telephone MoCA range from 0 to 22, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the Montréal Cognitive assessment will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Baseline cognitive testing will be performed before surgery, then repeated on postoperative day 15
Time frame
Postoperative day 154
Postoperative neurocognitive disorder day 30 (Yes/No); dichotomic result.
The presence of postoperative neurocognitive disorder will be evaluated using the Telephone Montreal Cognitive Assessment (T-MoCA) The Telephone MoCA range from 0 to 22, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the Montréal Cognitive assessment will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Baseline cognitive testing will be performed before surgery, then repeated on postoperative day 30
Time frame
Postoperative day 30Other outcomes
1
Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result; among prespecified subgroups of patients
The presence of postoperative neurocognitive disorder will be evaluated using the Montreal Cognitive Assessment (MoCA) The MoCA range from 0 to 30, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the Montréal Cognitive assessment will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Prespecified subgroups: * different surgical types (orthopedic, abdominal, gynecologic, urologic, thoracic), * different surgical duration (\[1-2 hours\], \[2-3h\], \> 3h), * patients with preoperative neurocognitive disorder (defined as a MoCA score at baseline \< 26), * frail patients (defined as a Clinical Frailty Scale ≥ 5 evaluated at baseline) * depressive patients (defined as a Patient Health Questionnaire 9 ≥ 10 evaluated at baseline) * patients ≥ 80 years old
Time frame
Postoperative day 12
Postoperative neurocognitive disorder day 2 (Yes/No); dichotomic result; among prespecified subgroups of patients
The presence of postoperative neurocognitive disorder will be evaluated using the Montreal Cognitive Assessment (MoCA) The MoCA range from 0 to 30, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the Montréal Cognitive assessment will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Prespecified subgroups: * different surgical types (orthopedic, abdominal, gynecologic, urologic, thoracic), * different surgical duration (\[1-2 hours\], \[2-3h\], \> 3h), * patients with preoperative neurocognitive disorder (defined as a MoCA score at baseline \< 26), * frail patients (defined as a Clinical Frailty Scale ≥ 5 evaluated at baseline) * depressive patients (defined as a Patient Health Questionnaire 9 ≥ 10 evaluated at baseline) * patients ≥ 80 years old
Time frame
Postoperative day 23
Postoperative neurocognitive disorder day 7 (Yes/No); dichotomic result; among prespecified subgroups of patients
The presence of postoperative neurocognitive disorder will be evaluated using the Telephone Montreal Cognitive Assessment (MoCA) The T-MoCA range from 0 to 30, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the T-MoCA will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Prespecified subgroups: * different surgical types (orthopedic, abdominal, gynecologic, urologic, thoracic), * different surgical duration (\[1-2 hours\], \[2-3h\], \> 3h), * patients with preoperative neurocognitive disorder (defined as a MoCA score at baseline \< 26), * frail patients (defined as a Clinical Frailty Scale ≥ 5 evaluated at baseline) * depressive patients (defined as a Patient Health Questionnaire 9 ≥ 10 evaluated at baseline) * patients ≥ 80 years old
Time frame
Postoperative day 74
Postoperative neurocognitive disorder day 15 (Yes/No); dichotomic result; among prespecified subgroups of patients
The presence of postoperative neurocognitive disorder will be evaluated using the Telephone Montreal Cognitive Assessment (MoCA) The T-MoCA range from 0 to 30, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the T-MoCA will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Prespecified subgroups: * different surgical types (orthopedic, abdominal, gynecologic, urologic, thoracic), * different surgical duration (\[1-2 hours\], \[2-3h\], \> 3h), * patients with preoperative neurocognitive disorder (defined as a MoCA score at baseline \< 26), * frail patients (defined as a Clinical Frailty Scale ≥ 5 evaluated at baseline) * depressive patients (defined as a Patient Health Questionnaire 9 ≥ 10 evaluated at baseline) * patients ≥ 80 years old
Time frame
Postoperative day 15Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ciusss de L'Est de l'Île de Montréal
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov