Clinical Trials Directory

Trials / Terminated

TerminatedNCT03337282

Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients

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

Status
Terminated
Phase
Study type
Observational
Enrollment
23 (actual)
Sponsor
Ciusss de L'Est de l'Île de Montréal · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREProtocolized 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.

Timeline

Start date
2017-09-21
Primary completion
2021-09-30
Completion
2021-09-30
First posted
2017-11-08
Last updated
2021-10-08

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03337282. Inclusion in this directory is not an endorsement.