Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT04787536

Conditions

Postoperative Cognitive Dysfunction

Depressive Symptoms

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Non-cardiac surgery

Study Details

Brief 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. 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.

Conditions

Postoperative Cognitive Dysfunction

Depressive Symptoms

Postoperative Pain

Study ID

NCT04787536

Start date

Jun 10, 2020

Status verified date

Oct, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Jan 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. age 65 years or greater;
2. patient scheduled to perform noncardiac elective surgery expected to require at least an overnight stay in hospital after surgery;
3. surgery deferred, with a known or probable surgery date in ≥6 weeks;
4. informed consent provided.

Exclusion Criteria:

1. patient undergoing cardiac surgery or cranial neurosurgery;
2. known history of dementia;
3. 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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Non-cardiac surgery

Non-cardiac surgery excluding cranial neurosurgery

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 ]

Central Contacts and Locations

Central contacts

Maura Marcucci, MD

9055274322marcum2@mcmaster.ca

Maram Khaled, MBBCh, MSc

9059220293khalem3@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4L8

Contacts

Maura Marcucci, MD

9055274322marcum2@mcmaster.ca

Maram Khaled, MBBCh, MSc

9059220293khalem3@mcmaster.ca

Principal Investigator:

Philippe Violette, MD

More Information

Sponsor

McMaster University

Last update posted

Oct 31, 2022

Last verified

Oct, 2022

Keywords

  • Older patients
  • Non-cardiac surgery
  • Cognitive trajectories

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2022-10-31.