Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
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ClinicalTrials.gov Identifier: NCT03337282 |
Recruitment Status :
Terminated
(Elderly population difficult to recruit)
First Posted : November 8, 2017
Last Update Posted : October 8, 2021
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Condition or disease | Intervention/treatment |
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Delirium Cognitive Impairment Cognitive Decline Cognitive Change Postoperative Cognitive Dysfunction Postoperative Delirium | Procedure: Protocolized general anesthesia |
Study Type : | Observational |
Actual Enrollment : | 23 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients Following Major Surgery Under Standardized General Anesthesia With Tight Hemodynamic Control: A Prospective Observational Study |
Actual Study Start Date : | September 21, 2017 |
Actual Primary Completion Date : | September 30, 2021 |
Actual Study Completion Date : | September 30, 2021 |
Group/Cohort | Intervention/treatment |
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Observational cohort
Adults 70 years of age or older undergoing major noncardiac surgery under protocolized general anesthesia
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Procedure: Protocolized general anesthesia
Induction and maintenance of general anesthesia, post-operative analgesia with protocolized drugs and doses. Maintenance of MAP +/- 20% of baseline with vasopressors as needed. |
- Post-operative cognitive dysfunction [ Time Frame: Baseline cognitive testing will be performed before surgery, then repeated on day before discharge or post-operative day 7 and then again at approximately post-operative day 30. ]Presence of post-operative cognitive dysfunction as determined by neuropsychological tests. A diagnosis of POCD will be made under the follow circumstances: a) A decrease in score from one assessment to the next (e.g., postoperatively vs. preoperatively) that results in the subject changing from within normal limits to below normal limits on the Montreal Cognitive Assessment (MoCA) b) A decrease in score of ≥ 1 standard deviation on the normed tests (MoCA, verbal fluency
- Post-operative delirium [ Time Frame: Post-operative days 1 and 2 ]Participants will be assessed for delirium via administration of the Confusion Assessment Method
- Self-assessment of applied cognitive abilities [ Time Frame: Pre-operatively, then post-operatively on day before discharge or post-operative day 7, then again on approximately post-operative day 30 ]The PROMIS self-assessment questionnaire "Applied cognition - Abilities" will be administered

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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 70 years of age or older
- Undergoing elective abdominal, gynecological, or urological surgery requiring post-operative hospitalization and with an expected anesthesia time of 60 minutes or more
- Seen in pre-operative clinic of Maisonneuve-Rosemont hospital
Exclusion Criteria:
- Known dementia or other cognitive impairment
- Psychiatric disease
- Significant hearing or vision impairment
- Inability to communicate in French
- Allergy or other contraindication to medications in standardized anesthesia protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337282
Canada, Quebec | |
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal | |
Montréal-Est, Quebec, Canada, H1T2M4 |
Principal Investigator: | Philippe Richebé, MD, PhD | Université de Montréal |
Responsible Party: | Philippe Richebe, Professor, DIrector of Research, Department of Anesthesiology, Université de Montréal, Ciusss de L'Est de l'Île de Montréal |
ClinicalTrials.gov Identifier: | NCT03337282 |
Other Study ID Numbers: |
2018-1197 |
First Posted: | November 8, 2017 Key Record Dates |
Last Update Posted: | October 8, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
anesthesia noncardiac surgery major surgery POCD |
Delirium Postoperative Cognitive Complications Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders Confusion Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |