The Montreal Cognitive Assessment as a Screening Tool for Preoperative Mild Cognitive Impairment in Geriatric Patients

Mild Cognitive Impairment Clinical Trial

— MoCA  

Official title:

The Montreal Cognitive Assessment as a Screening Tool for Preoperative Mild Cognitive

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01496222
• Other study ID #: 460/2554(EC2)
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 15, 2011
• Last updated: March 14, 2016
• Start date: January 2012
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

This is a prospective, double-blinded, control trial. The Montreal Cognitive Assessment is used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients, scheduled for general, vascular or urological surgery under general and/or regional anesthesia.

Description:

At the preoperative visit, the co-researcher invites 322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who meet the inclusion criteria to join the study. The process of the project is explained to the interested patients in details before an informed consent is obtained.

All participants are interviewed by using the Montreal Cognitive Assessment test. The history of drug used preoperatively (medication reconciliation) has also been recorded.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 582
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• male or female aged 65 yr, ASA I-III scheduled for elective general, vascular or urological surgery under general and/or regional anesthesia.

Exclusion Criteria:

• unable to communicate in reading and writing

• psychosomatic patients

• insulin-dependant diabetes

• renal insufficiency (creatinine >1.5 mg/dL), renal dialysis

• uncontrolled congestive heart failure (American Heart Association Classification III or IV congestive heart failure), unstable angina, untreated cardiac arrhythmia

• active gastrointestinal bleeding.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of mild cognitive impairment in preoperative geriatric patients		1 Year	Yes
Secondary	Relationship between mild cognitive impairment and drug used preoperatively in geriatric patients	Pearson correlation coefficient will be used to evaluate the relationship between mild cognitive impairment and drug used preoperatively in geriatric patients.	1 year	Yes