Clinical trial NCT03337282: Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Delirium
Cognitive Impairment
Cognitive Decline
Cognitive Change
Postoperative Cognitive Dysfunction
Postoperative Delirium
Keywords: anesthesia
noncardiac surgery
major surgery
POCD
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 23
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly Quebec francophone patients undergoing elective major non-cardiac surgery.

Brief summary: The purpose of this study is to determine what percentage of patients have cognitive problems (for example, memory or concentration difficulties) after surgery and anesthesia, what the characteristics of these problems are, and whether they persist over time. In particular, the investigators want to study this in the French-speaking Quebec population with cognitive evaluation tools adapted for this population.

Detailed description: Multiple experimental and observational studies have established that a non-negligible percentage of individuals undergoing surgery and anesthesia will experience a postoperative decline in mental abilities. These cognitive changes can range from postoperative delirium to more subtle and longer lasting (weeks to months) impairments; these latter changes are often referred to in the literature as postoperative cognitive dysfunction (POCD). While the precise causes of POCD remain nebulous, a clear epidemiological risk factor is advanced age - a demographic group that accounts for an increasing percentage of elective surgeries in North America. Several RCTs have attempted to link specific aspects of anesthesia, such as depth of anesthesia, regional vs general anesthesia, hemodynamic parameters, specific anesthetic agents, etc., to the risk of developing POCD in both the elderly and general populations. Results have often been conflicting and, based on current evidence, it is difficult to identify any specific anesthetic strategy that clearly reduces the risk of POCD. The present study aims to establish the incidence and neuropsychological characteristics of POCD in the investigator's local patient population as well as to establish the feasibility of pre- and postoperative cognitive testing with assessment tools adapted to and validated for Quebec francophones in order to lay the groundwork for future studies by the research group of interventions targeting specific anesthetic techniques and monitoring modalities.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative cognitive dysfunction
timeFrame: 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.
Secondary outcomes:
measure: Post-operative delirium
timeFrame: Post-operative days 1 and 2
measure: Self-assessment of applied cognitive abilities
timeFrame: Pre-operatively, then post-operatively on day before discharge or post-operative day 7, then again on approximately post-operative day 30
Other outcomes:
Locations:
city: Montréal-Est
country: Canada
facility: Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Philippe Richebé, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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