ClinicalTrials.gg
TerminatedNCT03337282Updated Oct 8, 2021

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

An observational study in Delirium, Cognitive Impairment and Cognitive Decline, sponsored by Ciusss de L'Est de l'Île de Montréal. Terminated at 1 site in Canada. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2021-10-08.

Primary conditionEmergence DeliriumRegistry: DeliriumReclassifiedWhy we changed it
Registry
Delirium — the first condition term the registry derived for this study.
ClinicalTrials.gg
Emergence Delirium
Why
  1. The study's listed conditions name Emergence Delirium, a narrower term within Delirium.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Ciusss de L'Est de l'Île de Montréal · Observational

Why this study was terminated
Elderly population difficult to recruit

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
23
Ages
70 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Emergence Delirium with a site in Canada — 5 open to participants now, 6 under way, none of them phase 3. Emergence Delirium · Canada.

Started
2017
with 1 other
Observational
4 of 16
1 open now
Registered
5th of 16
by date
Lead sponsor
1 of 16
Ciusss de L'Est de l'Île de Montréal

Among the 16 studies in Emergence Delirium with a site in Canada, this one is one of 2 that started in 2017, is one of 4 observational ones, and was the 5th registered.

Emergence Delirium

752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

Browse Emergence Delirium studies →

Open to participants now

5 of the 16 studies in Emergence Delirium with a site in Canada are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 143 Emergence Delirium studies recruiting now, 79 (55%) set no upper age limit and 44 (31%) stop at 75 or younger; 34 take children under 18; 24 take healthy volunteers.

This study: 70 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Emergence Delirium with a site in Canada, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

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

Keywords

  • anesthesia
  • noncardiac surgery
  • major surgery
  • POCD
04

In context

Emergence Delirium Reclassified

752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

This study's enrollment of 23 is below the median of 164 across 278 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Ciusss de L'Est de l'Île de Montréal is the lead sponsor of 90 studies on the registry; 32 are open to participants now.

Compared within Emergence Delirium, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Delirium. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Elderly Quebec francophone patients undergoing elective major non-cardiac surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Known dementia or other cognitive impairment
  • Psychiatric disease
  • Significant hearing or vision impairment
  • Inability to communicate in French
  • Allergy or other to medications in standardized anesthesia protocol
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
23 participants (actual)
Patient registry
No

Groups and cohorts

  • Observational cohort

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

    Procedure: Protocolized general anesthesia

Interventions

  • ProcedureProtocolized 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.

07

What researchers measure

Primary outcomes

  1. Post-operative cognitive dysfunction

    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

    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.

Secondary outcomes

  1. Post-operative delirium

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

    Time frame: Post-operative days 1 and 2

  2. Self-assessment of applied cognitive abilities

    The PROMIS self-assessment questionnaire "Applied cognition - Abilities" will be administered

    Time frame: Pre-operatively, then post-operatively on day before discharge or post-operative day 7, then again on approximately post-operative day 30

08

Study locations

1 site
  • Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
    Montréal-Est, Quebec H1T2M4, Canada
09

References and documents

Publications

  • 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. PubMed 25639374 ↗
  • 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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991. doi: 10.1111/jgs.15925. PubMed 15817019 ↗
  • 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. PubMed 2240918 ↗
  • 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. PubMed 24733193 ↗
  • 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. PubMed 27279436 ↗
  • 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. PubMed 27863317 ↗
  • 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. PubMed 20054838 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Sep 2021, 48 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2017
First posted
Nov 8, 2017
StartActual
Sep 21, 2017
Primary completionActual
Sep 30, 2021
CompletionActual
Sep 30, 2021
Last update
Oct 8, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03337282
Lead sponsor
Ciusss de L'Est de l'Île de Montréal
Responsible party
Philippe Richebe (Professor, DIrector of Research, Department of Anesthesiology, Université de Montréal, Ciusss de L'Est de l'Île de Montréal) — Principal investigator
First posted
Nov 8, 2017
Start date
Sep 21, 2017
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021
Last update
Oct 8, 2021

Study contacts

Philippe Richebé, MD, PhD
principal investigator · Université de Montréal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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