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

NCT03337282 | Terminated

• 1 other identifier: 2018-1197
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium; Cognitive Impairment; Cognitive Decline; Cognitive Change; Postoperative Cognitive Dysfunction; Postoperative Delirium

Keywords

anesthesia; noncardiac surgery; major surgery; POCD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Post-operative delirium

  Post-operative days 1 and 2

• Self-assessment of applied cognitive abilities

  Pre-operatively, then post-operatively on day before discharge or post-operative day 7, then again on approximately post-operative day 30

Study Arms (1)

Observational cohort

Adults 70 years of age or older undergoing major noncardiac surgery under protocolized general anesthesia

Procedure: Protocolized general anesthesia

Interventions

Protocolized general anesthesia PROCEDURE

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

Observational cohort

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly Quebec francophone patients undergoing elective major non-cardiac surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal

Montreal East, Quebec, H1T2M4, Canada

Location

Related Publications (7)

• Saffer BY, Lanting SC, Koehle MS, Klonsky ED, Iverson GL. Assessing cognitive impairment using PROMIS((R)) 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.

  PMID: 25639374 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian 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. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• 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. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

• 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.

  PMID: 24733193 BACKGROUND

• 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.

  PMID: 27279436 BACKGROUND

• Howland M, Tatsuoka C, Smyth KA, Sajatovic M. Evaluating PROMIS((R)) 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.

  PMID: 27863317 BACKGROUND

• Vercambre MN, Cuvelier H, Gayon YA, Hardy-Leger 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.

  PMID: 20054838 BACKGROUND

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications; Emergence Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Postoperative Complications; Pathologic Processes

Study Officials

• Philippe Richebé, MD, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DIrector of Research, Department of Anesthesiology, Université de Montréal

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: September 21, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)