We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03337282
Recruitment Status : Terminated (Elderly population difficult to recruit)
First Posted : November 8, 2017
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Philippe Richebe, 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.

Condition or disease Intervention/treatment
Delirium Cognitive Impairment Cognitive Decline Cognitive Change Postoperative Cognitive Dysfunction Postoperative Delirium 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.

Layout table for study information
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
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Post-operative delirium [ Time Frame: 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 [ 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elderly Quebec francophone patients undergoing elective major non-cardiac surgery.
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Quebec
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
Layout table for investigator information
Principal Investigator: Philippe Richebé, MD, PhD Université de Montréal
Publications:

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe Richebe, Ciusss de L'Est de l'Île de Montréal:
anesthesia
noncardiac surgery
major surgery
POCD
Additional relevant MeSH terms:
Layout table for MeSH terms
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