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Neurocognitive Disorders After Major Surgery in Elderly (POEGEA)

Primary Purpose

Anesthesia, Neurocognitive Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BIS monitor
Control group
Sponsored by
Ciusss de L'Est de l'Île de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Anesthesia, Processed EEG Monitor, Neurocognitive disorders, Major surgery, Burst Suppression, MoCA

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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,
  • Inability to communicate in French or English.

Sites / Locations

  • CIUSSS de l'Est de l'Île de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Electroencephalographic (EEG)-guided group

Standard Care (SC) group

Arm Description

Information 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.

In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at [0.8-1.2] MAC.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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
Postoperative neurocognitive disorder day 90 (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 90
Postoperative neurocognitive disorder evaluated on verbal fluency (Yes/No); dichotomic result.
The verbal fluency test consists of asking a patient to report as many word as possible in 1 minutes for a given letter (ex: as many "F" words as possible in 1 minutes) The verbal fluency test has no unit. It starts from 0 and has no maximum value. Higher values corresponding to The preoperative mean and standard deviation of the Verbal fluency will be calculated for the overall population. An individual reduction of the verbal fluency test ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder evaluated on verbal fluency (Yes/No). Baseline cognitive testing will be performed before surgery, then repeated on postoperative day 1,2,7,15,30 and 90
Cognitive Trajectories: Evolution of T-MoCA over time (score /22 without unit)
The Telephone version of the Montréal Cognitive Assessment is a short form of the Montreal cognitive assessment The Telephone MoCA ranges from 0 to 22, higher values corresponding to better cognitive performances. The MoCA ranges from 0 to 30, higher values corresponding to better cognitive performances. The T-MoCA is included in the MoCA T-MoCA part of the MoCA test will be used at day 0 and postoperative days 1 and 2 T-MoCA will be used at postoperative Day 7,15, 30 and 90 The evolution of these scores will establish cognitive trajectories.
Postoperative delirium (Yes/No); dichotomic result
Participants will be assessed for delirium via administration of the Confusion Assessment Method
Total Dose of Remifentanil (unit: mcg)
Total dose of remifentanil in mcg from induction of anesthesia until tracheal extubation
Total Dose of Sevoflurane (unit: ml)
Total dose of sevoflurane in ml from induction of anesthesia until tracheal extubation
Total Dose of Phenylephrine (unit: mcg)
Total dose of phenylephrine in ml from induction of anesthesia until tracheal extubation
Total hypotension duration (unit: minutes)
Baseline mean arterial blood pressure (MAP) will be defined as the average of 3 consecutive values taken 1 min apart and determined before the induction of general anesthesia. personalized objectives of intraoperative MAP will be defined as Baseline MAP +/- 20%. Total hypotension time will be defined as the cumulative time below Baseline MAP - 20% from induction of anesthesia until tracheal extubation.
Total cerebral hypoxemia duration (unit: minutes)
Baseline cerebral oxygen saturation (rSO2) will be defined as the average of 3 consecutive values taken 1 min apart and determined before the induction of general anesthesia. a decrease of 20% of the baseline rSO2 will define cerebral hypoxemia Total cerebral hypoxemia time will be defined as the cumulative time in cerebral hypoxemia from induction of anesthesia until tracheal extubation
Total burst suppression duration (unit: minutes)
Processed BIS EEG monitor provides a suppression time value corresponding to the cumulative time spent in burst suppression. Total burst suppression time will be measured from induction of anesthesia until tracheal extubation
Total low BIS values duration (unit: minutes)
Low BIS values will be defined as a BIS value under 40 (no unit for the BIS value) Total low BIS values duration will be defined as the cumulative time under 40 from anesthesia induction until tracheal extubation
Awareness (Yes/no); dichotomic result
Patient reported postoperative recall of sensory perception during general anaesthesia

Full Information

First Posted
March 26, 2021
Last Updated
October 17, 2023
Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT04825847
Brief Title
Neurocognitive Disorders After Major Surgery in Elderly
Acronym
POEGEA
Official Title
Effect of Electroencephalography-guided Anesthesia on Neurocognitive Disorders in Elderly Patients Undergoing Major Non-cardiac Surgery: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The main objective of the study is to investigate the effect of EEG-guided anesthesia aiming at reducing anesthetic administration and minimizing burst suppression on the EEG during general anesthesia on the incidence of NCD at postoperative day 1 in elderly patients (> 70 years old) undergoing major (expected duration > 1h) non-cardiac surgery compared to standard care. Secondary objectives are to investigate the effect of EEG-guided anesthesia compared to standard care on: neurocognitive disorders at postoperative day 2, 7, 15, 30 and 90, perioperative cognitive trajectories, postoperative delirium, intraoperative consumption of volatile anesthetics, opioids and vasopressors, intraoperative hypotension (number of interventions to treat hypotensive events), cerebral hypoxemia (assessed by cerebral oximetry), cumulative burst suppression duration and cumulative low processed EEG values duration during anesthesia, awareness postoperative surgical and quality of life / recovery outcomes. Tertiary objectives are to: explore the effect of EEG-guided anesthesia compared to standard care across and within subgroups including different categories of surgical, duration of surgery, preoperative frailty, preoperative presence of depressive symptoms, age and patients with preoperative neurocognitive disorder. explore the effect of a possible imbalance in risk factors for postoperative NCD between the two groups on the incidence of postoperative NCD. Methods Participants 314 patients 70 years of age or older scheduled for elective major gynecologic, abdominal, urologic, thoracic or orthopedic surgeries via laparoscopy or laparotomy under general anesthesia and an anesthesia time of more than 60 minutes at the institution HMR-CEMTL, who are seen at the preoperative clinic (CIEPC) by internal medicine and/or anesthesiology. Exclusion criteria: patients with known diagnosis of dementia or other neurological, psychiatric, developmental or medical condition that resulted in severe documented 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, inability to communicate in French or English will not be included in the present study. Anesthesia Protocol All patients will undergo general anesthesia with the following: induction with IV slow boluses of lidocaine to numb the vein, propofol 1.5mg.kg-1, remifentanil 1µg.kg-1, rocuronium 0.8mg.kg-1. The maintenance of anesthesia will be based on sevoflurane to reach [0.8-1.2] minimal alveolar concentration (MAC adjusted to age) in the control group, and to achieve a Bispectral index (BIS) of [40-60] in the EEG-guided group (see below). The Nociception level (NOL) index (PMD200™ device, Medasense Biometrics Ltd, Ramat Gan, Israel) and the bilateral cerebral regional oximetry (rSO2) (Invos™, Medtronic, Canada) will be placed and available for both groups throughout the entire anesthesia. Remifentanil infusion will be set between 0.02 and 0.3 µg.kg-1.min-1 to achieve a NOL index of [5-25]. Phenylephrine will be started at 0.2 µg.kg-1.min-1 and adjusted to maintain +/- 20% of the baseline values of the pre-anesthesia mean arterial pressure (MAP). No benzodiazepines or ketamine will be used intraoperatively. An epidural may be placed at the discretion of the anesthesiologist in charge of the patient in the OR. Patients will receive standard prophylaxis against postoperative nausea and vomiting. Hydromorphone PCA (or hydromorphone SC or PO if patient is not a candidate for PCA) for postoperative pain scores < 4/10, or Patient controlled epidural analgesia if an epidural is started in Postoperative anesthesia care unit (PACU). All anesthesia related side effects and quality of analgesia and rehabilitation will be evaluated for 48h. Intervention Patients will be randomized (1:1) to receive EEG guided anesthesia versus standard of care. Information 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. In the standard of care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at [0.8-1.2] MAC. Cognitive Assessment Participants will undergo cognitive assessment preoperatively to establish a baseline and then postoperatively to assess change from that baseline at postoperative days 1, 2, 7, 15, 30 and 90. The MoCA or the telephone version of the MoCA (T-MoCA) will be administered at each time point depending on patient location (hospital / home). Verbal fluency including phonemic and categorical fluency will be administered at each time point The Confusion Assessment Method (CAM) will be used to diagnose postoperative delirium at postoperative days 1 and 2. The Quality of Recovery-15 (QoR-15) questionnaire will be used at postoperative day 30 and 90 to explore quality of life after anesthesia and surgery. Significance/Importance This study was designed to explore the effect of EEG-guided anesthesia on perioperative neurocognitive disorders with tight control of intraoperative blood pressure and nociception level. Understanding EEG patterns of anesthesia to individualize titration of hypnotic drugs may help in reducing the incidence of perioperative neurocognitive disorders, particularly in the elderly. Study Design Prospective monocentric randomized controlled trial. Subject Population Patients ≥ 70 years old scheduled for major non-cardiac surgery (expected duration ≥1h). Sample Size Three hundred and fourteen (314 total; 157 per group, 2 groups) will be included in the present study. Study Duration 2 years. Study Center Single centre study, at Maisonneuve-Rosemont Hospital (HMR), Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de l'Ile de Montréal (CEMTL), Montréal, Québec, Canada. Adverse Events Non expected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Neurocognitive Disorders
Keywords
Anesthesia, Processed EEG Monitor, Neurocognitive disorders, Major surgery, Burst Suppression, MoCA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective monocentric randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Only the anesthesiologist in charge in the operating room will be aware of treatment group
Allocation
Randomized
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroencephalographic (EEG)-guided group
Arm Type
Active Comparator
Arm Description
Information 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.
Arm Title
Standard Care (SC) group
Arm Type
Active Comparator
Arm Description
In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at [0.8-1.2] MAC.
Intervention Type
Device
Intervention Name(s)
BIS monitor
Intervention Description
Information 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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at [0.8-1.2] MAC.
Primary Outcome Measure Information:
Title
Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result.
Description
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 1
Secondary Outcome Measure Information:
Title
Postoperative neurocognitive disorder day 2 (Yes/No); dichotomic result.
Description
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 2
Title
Postoperative neurocognitive disorder day 7 (Yes/No); dichotomic result.
Description
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 7
Title
Postoperative neurocognitive disorder day 15 (Yes/No); dichotomic result.
Description
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 15
Title
Postoperative neurocognitive disorder day 30 (Yes/No); dichotomic result.
Description
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 30
Title
Postoperative neurocognitive disorder day 90 (Yes/No); dichotomic result.
Description
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 90
Time Frame
Postoperative day 90
Title
Postoperative neurocognitive disorder evaluated on verbal fluency (Yes/No); dichotomic result.
Description
The verbal fluency test consists of asking a patient to report as many word as possible in 1 minutes for a given letter (ex: as many "F" words as possible in 1 minutes) The verbal fluency test has no unit. It starts from 0 and has no maximum value. Higher values corresponding to The preoperative mean and standard deviation of the Verbal fluency will be calculated for the overall population. An individual reduction of the verbal fluency test ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder evaluated on verbal fluency (Yes/No). Baseline cognitive testing will be performed before surgery, then repeated on postoperative day 1,2,7,15,30 and 90
Time Frame
Day 0,1, 2, 7, 15, 30, 90
Title
Cognitive Trajectories: Evolution of T-MoCA over time (score /22 without unit)
Description
The Telephone version of the Montréal Cognitive Assessment is a short form of the Montreal cognitive assessment The Telephone MoCA ranges from 0 to 22, higher values corresponding to better cognitive performances. The MoCA ranges from 0 to 30, higher values corresponding to better cognitive performances. The T-MoCA is included in the MoCA T-MoCA part of the MoCA test will be used at day 0 and postoperative days 1 and 2 T-MoCA will be used at postoperative Day 7,15, 30 and 90 The evolution of these scores will establish cognitive trajectories.
Time Frame
Day 0,1, 2, 7, 15, 30, 90
Title
Postoperative delirium (Yes/No); dichotomic result
Description
Participants will be assessed for delirium via administration of the Confusion Assessment Method
Time Frame
Postoperative days 1 and 2
Title
Total Dose of Remifentanil (unit: mcg)
Description
Total dose of remifentanil in mcg from induction of anesthesia until tracheal extubation
Time Frame
Intraoperative
Title
Total Dose of Sevoflurane (unit: ml)
Description
Total dose of sevoflurane in ml from induction of anesthesia until tracheal extubation
Time Frame
Intraoperative
Title
Total Dose of Phenylephrine (unit: mcg)
Description
Total dose of phenylephrine in ml from induction of anesthesia until tracheal extubation
Time Frame
Intraoperative
Title
Total hypotension duration (unit: minutes)
Description
Baseline mean arterial blood pressure (MAP) will be defined as the average of 3 consecutive values taken 1 min apart and determined before the induction of general anesthesia. personalized objectives of intraoperative MAP will be defined as Baseline MAP +/- 20%. Total hypotension time will be defined as the cumulative time below Baseline MAP - 20% from induction of anesthesia until tracheal extubation.
Time Frame
Intraoperative
Title
Total cerebral hypoxemia duration (unit: minutes)
Description
Baseline cerebral oxygen saturation (rSO2) will be defined as the average of 3 consecutive values taken 1 min apart and determined before the induction of general anesthesia. a decrease of 20% of the baseline rSO2 will define cerebral hypoxemia Total cerebral hypoxemia time will be defined as the cumulative time in cerebral hypoxemia from induction of anesthesia until tracheal extubation
Time Frame
Intraoperative
Title
Total burst suppression duration (unit: minutes)
Description
Processed BIS EEG monitor provides a suppression time value corresponding to the cumulative time spent in burst suppression. Total burst suppression time will be measured from induction of anesthesia until tracheal extubation
Time Frame
Intraoperative
Title
Total low BIS values duration (unit: minutes)
Description
Low BIS values will be defined as a BIS value under 40 (no unit for the BIS value) Total low BIS values duration will be defined as the cumulative time under 40 from anesthesia induction until tracheal extubation
Time Frame
Intraoperative
Title
Awareness (Yes/no); dichotomic result
Description
Patient reported postoperative recall of sensory perception during general anaesthesia
Time Frame
Postoperative day 1
Other Pre-specified Outcome Measures:
Title
Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result; among prespecified subgroups of patients
Description
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 1
Title
Postoperative neurocognitive disorder day 2 (Yes/No); dichotomic result; among prespecified subgroups of patients
Description
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 2
Title
Postoperative neurocognitive disorder day 7 (Yes/No); dichotomic result; among prespecified subgroups of patients
Description
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 7
Title
Postoperative neurocognitive disorder day 15 (Yes/No); dichotomic result; among prespecified subgroups of patients
Description
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 15
Title
Postoperative neurocognitive disorder day 30 (Yes/No); dichotomic result; among prespecified subgroups of patients
Description
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 30
Title
Postoperative neurocognitive disorder day 90 (Yes/No); dichotomic result; among prespecified subgroups of patients
Description
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 90
Title
Risk difference between groups of Postoperative neurocognitive disorder adjusted for prespecified risk factors (no unit)
Description
In a case the investigators observe important quantitative imbalance between prognostic factors between the treatment groups, the investigators will conduct an adjusted analysis of the primary outcome. The investigators will estimate a standardized marginal average treatment effect (risk difference) model adjusted from 10 strata based on an estimated propensity score from neurocognitive disorder's risk factors (age, sex, preoperative MoCA score, Clinical frailty scale (CFS), Patient Health Questionnaire (PHQ) -9 and education level). The marginal risk difference will be reported with 95% confidence intervals, estimated by non-parametric bootstrap (10 000 replications).
Time Frame
Postoperative days 1,2, 7, 15, 30, 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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, Inability to communicate in French or English.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Richebé, MD, PHD
Phone
+1 (514) 252 3400
Ext
3193
Email
philippe.richebe@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia Godin
Phone
+1 (514) 252 3400
Ext
3193
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Richebé, MD, PhD
Organizational Affiliation
Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est de l'Ile de Montréal - Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIUSSS de l'Est de l'Île de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe PR Richebé, MD, PhD
Phone
5142523400
Ext
4620
Email
philippe.richebe@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Nadia NG Godin
Phone
5142523400
Ext
3193
Email
ngodin.hmr@ssss.gouv.qc.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
34375362
Citation
Morisson L, Laferriere-Langlois P, Carrier FM, Page G, Godbout C, Fortier LP, Ogez D, Letourneau G, Jarry S, Denault A, Fortier A, Guertin MC, Verdonck O, Richebe P. Effect of electroencephalography-guided anesthesia on neurocognitive disorders in elderly patients undergoing major non-cardiac surgery: A trial protocol The POEGEA trial (POncd Elderly GEneral Anesthesia). PLoS One. 2021 Aug 10;16(8):e0255852. doi: 10.1371/journal.pone.0255852. eCollection 2021.
Results Reference
derived

Learn more about this trial

Neurocognitive Disorders After Major Surgery in Elderly

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