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

NCT ID: NCT03337282

Last Updated: 2021-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-21

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Delirium Cognitive Impairment Cognitive Decline Cognitive Change Postoperative Cognitive Dysfunction Postoperative Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational cohort

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

Protocolized general anesthesia

Intervention Type PROCEDURE

Induction and maintenance of general anesthesia, post-operative analgesia with protocolized drugs and doses. Maintenance of MAP +/- 20% of baseline with vasopressors as needed.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Philippe Richebe

Professor, DIrector of Research, Department of Anesthesiology, Université de Montréal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Richebé, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

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Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal

Montreal East, Quebec, Canada

Site Status

Countries

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Canada

References

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Inouye SK, Kosar CM, Tommet D, Schmitt EM, Puelle MR, Saczynski JS, Marcantonio ER, Jones RN. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014 Apr 15;160(8):526-533. doi: 10.7326/M13-1927.

Reference Type BACKGROUND
PMID: 24733193 (View on PubMed)

St-Hilaire A, Hudon C, Vallet GT, Bherer L, Lussier M, Gagnon JF, Simard M, Gosselin N, Escudier F, Rouleau I, Macoir J. Normative data for phonemic and semantic verbal fluency test in the adult French-Quebec population and validation study in Alzheimer's disease and depression. Clin Neuropsychol. 2016 Oct;30(7):1126-50. doi: 10.1080/13854046.2016.1195014. Epub 2016 Jun 9.

Reference Type BACKGROUND
PMID: 27279436 (View on PubMed)

Howland M, Tatsuoka C, Smyth KA, Sajatovic M. Evaluating PROMIS((R)) applied cognition items in a sample of older adults at risk for cognitive decline. Psychiatry Res. 2017 Jan;247:39-42. doi: 10.1016/j.psychres.2016.10.072. Epub 2016 Nov 1.

Reference Type BACKGROUND
PMID: 27863317 (View on PubMed)

Vercambre MN, Cuvelier H, Gayon YA, Hardy-Leger I, Berr C, Trivalle C, Boutron-Ruault MC, Clavel-Chapelon F. Validation study of a French version of the modified telephone interview for cognitive status (F-TICS-m) in elderly women. Int J Geriatr Psychiatry. 2010 Nov;25(11):1142-9. doi: 10.1002/gps.2447.

Reference Type BACKGROUND
PMID: 20054838 (View on PubMed)

Saffer BY, Lanting SC, Koehle MS, Klonsky ED, Iverson GL. Assessing cognitive impairment using PROMIS((R)) applied cognition-abilities scales in a medical outpatient sample. Psychiatry Res. 2015 Mar 30;226(1):169-72. doi: 10.1016/j.psychres.2014.12.043. Epub 2015 Jan 8.

Reference Type BACKGROUND
PMID: 25639374 (View on PubMed)

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

Reference Type BACKGROUND
PMID: 15817019 (View on PubMed)

Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

Reference Type BACKGROUND
PMID: 2240918 (View on PubMed)

Other Identifiers

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2018-1197

Identifier Type: -

Identifier Source: org_study_id

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