Postoperative Cognitive DysfunctionCoTELE-SURGENCT04787536
Perioperative Cognitive Trajectories in Deferred Surgery (CoTELE-SURGE)
An observational study of Postoperative Cognitive Dysfunction and Depressive Symptoms, run by McMaster University at 1 site in Canada.
Trial summary
Cognition is the way people use their brains to think, understand, remember and make decisions. Cognitive changes are often seen even up to 1 year after surgery. Whether these changes are more than what is expected for someone's age and morbidities is still uncertain. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Depressive Symptoms, Postoperative Pain
- What is being tested?
- Non-cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2020to 30 Jun 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients 65 years or older undergoing non-cardiac non-cranial surgery scheduled to happen in 6 weeks or more and expected to stay for at least 1 night in the hospital postoperative.
Who may be able to join
- age 65 years or greater;
- patient scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery;
- surgery deferred, with a known or probable surgery date in ≥6 weeks;
- informed consent provided.
Who cannot join
- patient undergoing cardiac surgery or cranial neurosurgery;
- known history of dementia;
- unavailability of tablet or computer with an internet connection for remote assessment; 4. patient unable to interact with a tablet or computer due to language, visual, or hearing impairment, or any severely limited mobility of the upper limb joints;
- 5. patient unable to understand spoken or written English; 6. surgery delayed for an intercurrent clinical event
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4L8
Maura Marcucci, MD, 9055274322 ext. 40594, marcum2@mcmaster.ca
Maram Khaled, MBBCh, MSc, 9059220293, khalem3@mcmaster.ca
About this study
Official title: Preoperative and Postoperative Cognitive TrajEctories in oLdEr Patients With Deferred SURGEry Due to the COVID-19 Emergency: a Prospective Cohort Study
Cognition is the way people use their brains to think, understand, remember and make decisions. Cognitive changes are often seen even up to 1 year after surgery. Whether these changes are more than what is expected for someone's age and morbidities is still uncertain. Due to the COVID-19 emergency, many elective surgeries have been delayed, which is stressful for patients, but also represents an opportunity of understanding better how surgery can impact cognitive abilities. The purpose of this study is to explore if and how cognitive performance changes over time for patients aged 65 years or older, whose surgery has been postponed.
due to the COVID-19 emergency, following and assessing the cognitive performance of these patients over time before and after surgery. In particular, in this study, the participant's cognitive performance will be assessed periodically with a computer-based instrument for cognitive testing, self-administered at home, in which tests are based on playing cards.
Read the detailed description
The primary objectives of the project are to describe perioperative cognitive trajectories of older patients whose elective noncardiac surgery has been deferred because of the COVID-19 emergency, and explore the intra-individual changes in these trajectories from before to after surgery, through periodic remote self-administered cognitive testing. Secondarily, in the same patients, the investigators will also describe the perioperative trajectories in depressive symptoms and pain, and study their correlation with the trajectories in cognitive performance.
The study will be conducted remotely and virtually. The investigators will have an initial videoconference with the participant (and a support person if necessary) to explain the computerized cognitive test battery (i.e. the Cogstate Brief battery, CBB), and train on self-administration through a user-specific link. At each due assessment, the research team will call the participant to remind to complete the CBB; and to assess depressive symptoms, pain, and collect data on intercurrent clinical events (i.e. medication changes, hospitalization, ED or urgent care visits).
- Being tested
- Non-cardiac surgery
- Keywords
- Older patients, Non-cardiac surgery, Cognitive trajectories
- Medical subject headings
- Postoperative Cognitive Complications, Depression, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-cardiac surgeryProcedure or surgery
Non-cardiac surgery excluding cranial neurosurgery
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Patients aged 65 years or greater; scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery; surgery deferred, with a known or probable surgery date in ≥6 weeks Receives: Procedure: Non-cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perioperative cognitive trajectories assessed using the Cogstate Brief Battery (CBB)
CBB is a computer-based cognitive test extensively validated against standard neuropsychological batteries in cognitively normal older adults, as well as in patients with cognitive impairment, in the community and in different clinical contexts, both in a clinician/researcher-supervised manner, and in an unsupervised fashion. It has been used also in the perioperative setting, showing equivalent or greater reliability, and greater sensitivity than conventional batteries. It consists of four tasks (Detection Task, Identification Task, Learning Task, and One-Back Task) designed to assess psychomotor function, attention, working memory, and visual learning. Each task utilizes stimuli in the form of playing cards. Stimuli characteristics (e.g., color, suit) are manipulated based on the requirements of each task.
Measured: After 1-5 days from the initial recruitment, each participant will self-administer the cognitive testing once, and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
Secondary outcomes (2)
Pain trajectories using the Numeric Pain Rating Scale
The Numerical Pain Rating Scale (NPRS) is a rapid subjective measure of pain in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Correlation with other pain-assessment tools and feasibility of its use also in telephone interviews, have been demonstrated. The NPRS will be administered by the research personnel on the phone.
Measured: Baseline assessment after 1-5 days from the initial recruitment and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
Depressive symptoms trajectories using the Geriatric Depression Scale (short form) (GDS)
The short form (15-item) version of the GDS is widely used instrument, which has demonstrated good reliability and validity in assessing depressive symptoms in older adults. The GDS Short Form takes an average of 5 to 7 min to complete and will be administered by the research personnel on the phone.
Measured: Baseline assessment after 1-5 days from the initial recruitment and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start10 Jun 2020
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maura Marcucci, McMaster University
- Investigators
- Maura Marcucci, MD, Principal investigator, McMaster Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787536
- Sponsor's protocol ID
- 10829
- Acronym
- CoTELE-SURGE
- Status last verified
- Oct 2022
- First submitted
- 3 Mar 2021
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khaled M, Gutschon R, Bathini V, Martin P, Elmansy H, Devereaux PJ, Tiboni M, Harlock J, Cenic A, Sne N, Shargall Y, Nenshi R, Shanthanna H, Thabane L, Germini F, Korstensky M, Grami N, Selznick A, van Dyk C, Latchupatula L, Benayon M, Cotovio A, Hoffman A, Hircock C, Yaremko H, Chan O, Dennis M, Blasioli E, Sabac D, Sharma A, Krysiak K, Huan P, Gupta S, Borges FK, Ofori S, Maiorano S, Barisone M, Roldan Y, Sevestre M, Ferber M, Mulazzani F, Spence J, Violette PD, Marcucci M. The Co-TELE-SURGE study: A prospective cohort proof-of-concept study of perioperative cognitive trajectories in older adults undergoing noncardiac surgery. J Clin Anesth. 2026 Sep 22;115:112326. doi: 10.1016/j.jclinane.2026.112326. Online ahead of print.
PubMed 42790141
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative and Postoperative Cognitive TrajEctories in oLdEr Patients With Deferred SURGEry Due to the COVID-19 Emergency: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04787536
- Acronym / sponsor ID
- CoTELE-SURGE / 10829
- Keywords
- Older patients, Non-cardiac surgery, Cognitive trajectories
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Mar 2021 (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.
Cognition is the way people use their brains to think, understand, remember and make decisions. Cognitive changes are often seen even up to 1 year after surgery. Whether these changes are more than what is expected for someone's age and morbidities is still uncertain. Due to the COVID-19 emergency, many elective surgeries have been delayed, which is stressful for patients, but also represents an opportunity of understanding better how surgery can impact cognitive abilities. The purpose of this study is to explore if and how cognitive performance changes over time for patients aged 65 years or older, whose surgery has been postponed.
due to the COVID-19 emergency, following and assessing the cognitive performance of these patients over time before and after surgery. In particular, in this study, the participant's cognitive performance will be assessed periodically with a computer-based instrument for cognitive testing, self-administered at home, in which tests are based on playing cards.
Detailed description
The primary objectives of the project are to describe perioperative cognitive trajectories of older patients whose elective noncardiac surgery has been deferred because of the COVID-19 emergency, and explore the intra-individual changes in these trajectories from before to after surgery, through periodic remote self-administered cognitive testing. Secondarily, in the same patients, the investigators will also describe the perioperative trajectories in depressive symptoms and pain, and study their correlation with the trajectories in cognitive performance.
The study will be conducted remotely and virtually. The investigators will have an initial videoconference with the participant (and a support person if necessary) to explain the computerized cognitive test battery (i.e. the Cogstate Brief battery, CBB), and train on self-administration through a user-specific link. At each due assessment, the research team will call the participant to remind to complete the CBB; and to assess depressive symptoms, pain, and collect data on intercurrent clinical events (i.e. medication changes, hospitalization, ED or urgent care visits).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Procedure: Non-cardiac surgeryPatients aged 65 years or greater; scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery; surgery deferred, with a known or probable surgery date in ≥6 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients 65 years or older undergoing non-cardiac non-cranial surgery scheduled to happen in 6 weeks or more and expected to stay for at least 1 night in the hospital postoperative.
Key inclusion criteria (4 listed)
- age 65 years or greater;
- patient scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery;
- surgery deferred, with a known or probable surgery date in ≥6 weeks;
- informed consent provided.
Key exclusion criteria (4 listed)
- patient undergoing cardiac surgery or cranial neurosurgery;
- known history of dementia;
- unavailability of tablet or computer with an internet connection for remote assessment; 4. patient unable to interact with a tablet or computer due to language, visual, or hearing impairment, or any severely limited mobility of the upper limb joints;
- 5. patient unable to understand spoken or written English; 6. surgery delayed for an intercurrent clinical event
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 |
|---|---|---|
| Non-cardiac surgeryNon-cardiac surgery excluding cranial neurosurgery | Procedure or surgery | Study cohort |
Primary outcome
Change in perioperative cognitive trajectories assessed using the Cogstate Brief Battery (CBB)
Time frame: After 1-5 days from the initial recruitment, each participant will self-administer the cognitive testing once, and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
CBB is a computer-based cognitive test extensively validated against standard neuropsychological batteries in cognitively normal older adults, as well as in patients with cognitive impairment, in the community and in different clinical contexts, both in a clinician/researcher-supervised manner, and in an unsupervised fashion. It has been used also in the perioperative setting, showing equivalent or greater reliability, and greater sensitivity than conventional batteries. It consists of four tasks (Detection Task, Identification Task, Learning Task, and One-Back Task) designed to assess psychomotor function, attention, working memory, and visual learning. Each task utilizes stimuli in the form of playing cards. Stimuli characteristics (e.g., color, suit) are manipulated based on the requirements of each task.
2 secondary outcomes
Pain trajectories using the Numeric Pain Rating Scale
Time frame: Baseline assessment after 1-5 days from the initial recruitment and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
Depressive symptoms trajectories using the Geriatric Depression Scale (short form) (GDS)
Time frame: Baseline assessment after 1-5 days from the initial recruitment and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Derived from this study: PubMed 42790141Khaled M, Gutschon R, Bathini V, Martin P, Elmansy H, Devereaux PJ, Tiboni M, Harlock J, Cenic A, Sne N, Shargall Y, Nenshi R, Shanthanna H, Thabane L, Germini F, Korstensky M, Grami N, Selznick A, van Dyk C, Latchupatula L, Benayon M, Cotovio A, Hoffman A, Hircock C, Yaremko H, Chan O, Dennis M, Blasioli E, Sabac D, Sharma A, Krysiak K, Huan P, Gupta S, Borges FK, Ofori S, Maiorano S, Barisone M, Roldan Y, Sevestre M, Ferber M, Mulazzani F, Spence J, Violette PD, Marcucci M. The Co-TELE-SURGE study: A prospective cohort proof-of-concept study of perioperative cognitive trajectories in older adults undergoing noncardiac surgery. J Clin Anesth. 2026 Sep 22;115:112326. doi: 10.1016/j.jclinane.2026.112326. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Maura Marcucci, MD principal investigator
McMaster Univesity
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 Postoperative Cognitive Dysfunction and Depressive Symptoms, run by McMaster University 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maura Marcucci, MD (9055274322 ext. 40594, marcum2@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perioperative cognitive trajectories assessed using the Cogstate Brief Battery (CBB) (time frame: After 1-5 days from the initial recruitment, each participant will self-administer the cognitive testing once, and then every month until surgery. Postoperative assessments at 1, 3, 6 and 12 months postoperative). 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 NCT04787536, which also lists 1 linked publication.
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 31 Oct 2022.