Cognitive Impairment Clinical Trial
Official title:
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
Verified date | October 2021 |
Source | Ciusss de L'Est de l'Île de Montréal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 23 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | Inclusion Criteria: - 70 years of age or older - Undergoing elective abdominal, gynecological, or urological surgery requiring post-operative hospitalization and with an expected anesthesia time of 60 minutes or more - Seen in pre-operative clinic of Maisonneuve-Rosemont hospital Exclusion Criteria: - Known dementia or other cognitive impairment - Psychiatric disease - Significant hearing or vision impairment - Inability to communicate in French - Allergy or other contraindication to medications in standardized anesthesia protocol |
Country | Name | City | State |
---|---|---|---|
Canada | Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal | Montréal-Est | Quebec |
Lead Sponsor | Collaborator |
---|---|
Ciusss de L'Est de l'Île de Montréal |
Canada,
Howland M, Tatsuoka C, Smyth KA, Sajatovic M. Evaluating PROMIS(®) applied cognition items in a sample of older adults at risk for cognitive decline. Psychiatry Res. 2017 Jan;247:39-42. doi: 10.1016/j.psychres.2016.10.072. Epub 2016 Nov 1. — View Citation
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Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation
Saffer BY, Lanting SC, Koehle MS, Klonsky ED, Iverson GL. Assessing cognitive impairment using PROMIS(®) applied cognition-abilities scales in a medical outpatient sample. Psychiatry Res. 2015 Mar 30;226(1):169-72. doi: 10.1016/j.psychres.2014.12.043. Epub 2015 Jan 8. — View Citation
St-Hilaire A, Hudon C, Vallet GT, Bherer L, Lussier M, Gagnon JF, Simard M, Gosselin N, Escudier F, Rouleau I, Macoir J. Normative data for phonemic and semantic verbal fluency test in the adult French-Quebec population and validation study in Alzheimer's disease and depression. Clin Neuropsychol. 2016 Oct;30(7):1126-50. doi: 10.1080/13854046.2016.1195014. Epub 2016 Jun 9. — View Citation
Vercambre MN, Cuvelier H, Gayon YA, Hardy-Léger I, Berr C, Trivalle C, Boutron-Ruault MC, Clavel-Chapelon F. Validation study of a French version of the modified telephone interview for cognitive status (F-TICS-m) in elderly women. Int J Geriatr Psychiatry. 2010 Nov;25(11):1142-9. doi: 10.1002/gps.2447. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative cognitive dysfunction | Presence of post-operative cognitive dysfunction as determined by neuropsychological tests. A diagnosis of POCD will be made under the follow circumstances: a) A decrease in score from one assessment to the next (e.g., postoperatively vs. preoperatively) that results in the subject changing from within normal limits to below normal limits on the Montreal Cognitive Assessment (MoCA) b) A decrease in score of = 1 standard deviation on the normed tests (MoCA, verbal fluency | Baseline cognitive testing will be performed before surgery, then repeated on day before discharge or post-operative day 7 and then again at approximately post-operative day 30. | |
Secondary | Post-operative delirium | Participants will be assessed for delirium via administration of the Confusion Assessment Method | Post-operative days 1 and 2 | |
Secondary | Self-assessment of applied cognitive abilities | The PROMIS self-assessment questionnaire "Applied cognition - Abilities" will be administered | Pre-operatively, then post-operatively on day before discharge or post-operative day 7, then again on approximately post-operative day 30 |
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