DeliriumNCT03337282
Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
An observational study of Delirium and Cognitive Impairment, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium, Cognitive Impairment, Cognitive Decline
- What is being tested?
- Protocolized general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2017to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly Quebec francophone patients undergoing elective major non-cardiac surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
Montreal East, Quebec, H1T2M4
About this study
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
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.
- Conditions
- Delirium, Cognitive Impairment, Cognitive Decline, Cognitive Change, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Being tested
- Protocolized general anesthesia
- Keywords
- anesthesia, noncardiac surgery, major surgery, POCD
- Medical subject headings
- Delirium, Cognitive Dysfunction, Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized general anesthesiaProcedure or surgery
Induction and maintenance of general anesthesia, post-operative analgesia with protocolized drugs and doses. Maintenance of MAP +/- 20% of baseline with vasopressors as needed.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | Adults 70 years of age or older undergoing major noncardiac surgery under protocolized general anesthesia Receives: Procedure: Protocolized general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (2)
Post-operative delirium
Participants will be assessed for delirium via administration of the Confusion Assessment Method
Measured: Post-operative days 1 and 2
Self-assessment of applied cognitive abilities
The PROMIS self-assessment questionnaire "Applied cognition - Abilities" will be administered
Measured: Pre-operatively, then post-operatively on day before discharge or post-operative day 7, then again on approximately post-operative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start21 Sep 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Elderly population difficult to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Philippe Richebé, MD, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337282
- Sponsor's protocol ID
- 2018-1197
- Status last verified
- Oct 2021
- First submitted
- 6 Nov 2017
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25639374Nasreddine 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.
PubMed 15817019Inouye 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 2240918Inouye 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 24733193St-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 27279436Howland 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 27863317Vercambre 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03337282
- Acronym / sponsor ID
- 2018-1197
- Conditions
- Delirium, Cognitive Impairment, Cognitive Decline, Cognitive Change, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Keywords
- anesthesia, noncardiac surgery, major surgery, POCD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Elderly population difficult to recruit
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | Procedure: Protocolized general anesthesiaAdults 70 years of age or older undergoing major noncardiac surgery under protocolized general anesthesia |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly Quebec francophone patients undergoing elective major non-cardiac surgery.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocolized general anesthesiaInduction and maintenance of general anesthesia, post-operative analgesia with protocolized drugs and doses. Maintenance of MAP +/- 20% of baseline with vasopressors as needed. | Procedure or surgery | Observational cohort |
Primary outcome
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
2 secondary outcomes
Post-operative delirium
Time frame: Post-operative days 1 and 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
Results and safety
The study was stopped early (reason given: Elderly population difficult to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: PubMed 25639374Saffer 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.
- Background: PubMed 15817019Nasreddine 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.
- Background: PubMed 2240918Inouye 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.
- Background: PubMed 24733193Inouye 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.
- Background: PubMed 27279436St-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.
- Background: PubMed 27863317Howland 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.
- Background: PubMed 20054838Vercambre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Richebé, MD, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Cognitive Impairment, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Elderly population difficult to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03337282, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.