Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
NCT Number: NCT03147937
Patients assume that cognitive performance rapidly returns to baseline after anesthesia and surgery. Several studies have shown that one week after major non-cardiac surgery about 27% of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months. Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly reduces quality of life. Identifying risk factors for POCD is important because it is associated with prolonged hospital stay, loss of independence, and premature retirement. There is an urgent need to measure and document the level of cognitive change associated with surgery with an easy to use tool, both prior to admission and after discharge. This information can be used to plan appropriate care paths and to identify or test the efficacy of potential new treatments to alter the negative trajectory.
This study is active but is not currently recruiting participants.
50 year and older
All sexes
Observational
Toronto, Ontario, M4N 3M5, Canada
Postoperative cognitive dysfunction (POCD) is thought to affect a significant proportion of patients after major surgery (up to 10% at 3 months). This is potentially a major public health issue because patients with POCD have prolonged hospital admission, loss of independence and mortality. Undoubtedly, if POCD is as prevalent and devastating as has been previously reported, the decision to undergo elective surgery should be influenced by the risk of developing POCD. Given the scope of the issue, the deficiencies in the literature surrounding POCD are concerning. There are many methodological issues with previous studies and the diagnosis of POCD in the perioperative period.
It is imperative that the true natures of postoperative cognitive changes are elucidated so that preoperative risk stratification can be appropriately determined. This will lead to care pathways and interventions that can modify any possible downward changes thereby reducing the negative impact on patients and the health care system.
Main Study Hypothesis: The incidence of postoperative cognitive changes in the joint arthroplasty population is influenced by:
Study Objectives:
In patients undergoing primary total hip or knee arthroplasty the goals of this project are to:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Computerized CogState Brief Battery (CBB), Cognigram, assesses changes in four cognitive domains including psychomotor function, attention, learning and memory, and working memory. The CBB is a computerized test based on card games that can be administered online
Time frame: 4.5 months from baseline
Proportion of patients with Cognigram score decreasing by > 2 SDs from baseline at 4.5
Time frame: 4.5 months from baseline
Proportion of patients with Cognigram score decreasing between 1 and 2 standard deviations from baseline at 4.5 months
Time frame: 4.5 months from baseline
Effect of pre-operative MCI on postoperative cognitive changes at 4.5 months
Time frame: 4.5 months from baseline
Effect of pre-operative chronic inflammatory states on postoperative cognitive changes at 4.5 months
Time frame: 4.5 months from baseline
Effect of postoperative delirium on postoperative cognitive changes at 4.5 months
Time frame: 4.5 months from baseline
Effect of postoperative complications on postoperative cognitive changes at 4.5 months
Dr. Stephen Choi
Other
Assessing Postoperative Cognitive Changes After Major Joint Arthroplasty: A Prospective Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02964221
Cognition Disorders, Cognitive Change
View Trial DetailsNCT05464355
Brain Diseases, Central Nervous System Diseases
Reading, Berkshire, United Kingdom
View Trial DetailsNCT03480061
Behavior, Behavioral Symptoms
Toronto, Ontario, Canada
View Trial DetailsNCT03360838
Cardiac Surgery, Cognition Disorders
Basel, Switzerland
View Trial Details