Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients

Terminated

• Conditions: Delirium; Cognitive Decline; Postoperative Cognitive Dysfunction; Postoperative Delirium; Cognitive Impairment; Cognitive Change

• Registration Number: NCT03337282
• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal

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.

Study Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-08
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative cognitive dysfunction	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

Secondary Outcome Measures

Name	Time	Method
Post-operative delirium	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	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

Trial Locations

Locations (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal; 🇨🇦 Montréal-Est, Quebec, Canada