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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Phongthara Vichitvejpaisal", Mahidol University
ClinicalTrials.gov Identifier:
NCT01496222
First received: December 15, 2011
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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.


Condition
Mild Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Principal Investigator

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Incidence of mild cognitive impairment in preoperative geriatric patients [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Relationship between mild cognitive impairment and drug used preoperatively in geriatric patients [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Pearson correlation coefficient will be used to evaluate the relationship between mild cognitive impairment and drug used preoperatively in geriatric patients.


Enrollment: 582
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study enrolls 582 consecutive geriatric patients,322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who undergoing general and/or regional anesthesia.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496222

Locations
Thailand
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Phongthara Vichitvejpaisal, M.D., Ph.D. Faculty of Medicine Siriraj Hospital
  More Information

No publications provided

Responsible Party: Phongthara Vichitvejpaisal", Professor Dr., Mahidol University
ClinicalTrials.gov Identifier: NCT01496222     History of Changes
Other Study ID Numbers: 460/2554(EC2)
Study First Received: December 15, 2011
Last Updated: December 20, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
mild cognitive impairment
Montreal Cognitive Assessment test

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014