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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03337282
• Other study ID #: 2018-1197
• Status: Terminated
• Start date: September 21, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cognitive Change
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Delirium
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Postoperative Delirium

Intervention

Procedure:
• Protocolized general anesthesia
Induction and maintenance of general anesthesia, post-operative analgesia with protocolized drugs and doses. Maintenance of MAP +/- 20% of baseline with vasopressors as needed.

Locations

Country	Name	City	State
Canada	Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal	Montréal-Est	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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

Inouye SK, Kosar CM, Tommet D, Schmitt EM, Puelle MR, Saczynski JS, Marcantonio ER, Jones RN. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014 Apr 15;160(8):526-533. doi: 10.7326/M13-1927. — View Citation

Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. — View Citation

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

Outcome

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