Perioperative Cognitive Trajectories in Deferred Surgery (CoTELE-SURGE)

NCT04787536 | Unknown

• 1 other identifier: 10829
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Older patients; Non-cardiac surgery; Cognitive trajectories

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  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

Study Arms (1)

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

Procedure: Non-cardiac surgery

Interventions

Non-cardiac surgery PROCEDURE

Non-cardiac surgery excluding cranial neurosurgery

Study cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• \. patient unable to understand spoken or written English; 6. surgery delayed for an intercurrent clinical event

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications; Depression; Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Maura Marcucci, MD

  McMaster Univesity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maura Marcucci, MD

CONTACT

9055274322; marcum2@mcmaster.ca

Maram Khaled, MBBCh, MSc

CONTACT

9059220293; khalem3@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Health Research Methods, Evidence and Impact and Department of Medicine

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: June 10, 2020
• Primary Completion: January 31, 2023
• Study Completion: June 30, 2023
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

CA (1)