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

Sponsor
Ciusss de L'Est de l'Île de Montréal (Other)
Overall Status
Terminated
CT.gov ID
NCT03337282
Collaborator
(none)
23
1
48.3
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Protocolized general anesthesia

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 Design

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 :
Sep 21, 2017
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Observational cohort

Adults 70 years of age or older undergoing major noncardiac surgery under protocolized general anesthesia

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Post-operative delirium [Post-operative days 1 and 2]

    Participants will be assessed for delirium via administration of the Confusion Assessment Method

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal Montréal-Est Quebec Canada H1T2M4

Sponsors and Collaborators

  • Ciusss de L'Est de l'Île de Montréal

Investigators

  • Principal Investigator: Philippe Richebé, MD, PhD, Université de Montréal

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Nov 8, 2017
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Philippe Richebe, Professor, DIrector of Research, Department of Anesthesiology, Université de Montréal, Ciusss de L'Est de l'Île de Montréal
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021