Preoperative Risk Factors and Perioperative Neurocognitive Disorders

NCT03805685 | Completed

• 1 other identifier: Lifestyle-Delirium
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative neurocognitive disorders (PND's) remain an important complication after surgery. After many years of speculating about the etiology of this complication, currently studies are pointing to an inflammatory cascade being set in motion. This prospective study is designed to examine preoperative lifestyle factors (such as sedentary behavior) associated with postoperative cognitive impairment in a group of patients undergoing non-cardiac surgery. The objectives in our study are to: identify perioperative risk factors for the development of PND's measure the incidence and duration of perioperative neurocognitive disorders in a known high-risk group of elective surgical patients measure a peripheral inflammatory marker (interleukin 6: IL-6) in the same group of surgical patients

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (3)

• Pre-operative MMSE

  Mini mental state examination will be evaluated prior to the surgery

  12 hours

• MMSE 6 weeks post-operative

  Mini mental state examination will be evaluated 6 weeks after surgery

  6 weeks

• MMSE 3 months post-operative

  Mini mental state examination will be evaluated 3 months after surgery

  3 months

Secondary Outcomes (3)

• Concentration of patient's baseline pre-operative peripheral IL-6

  12 hours

• Concentration of patient's post-operative peripheral IL-6; 6 hours post-operative

  24 hours

• Concentration of patient's post-operative peripheral IL-6 ; 24 hours post-operative

  24 hours

Interventions

Non-Cardiac Surgery PROCEDURE

Non-cardiac surgery

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients participating in the study will have to provide written informed consent. Patients of both genders aged 55 or more scheduled for non-cardiac surgery between 8 and 10 AM (with a duration of 1 to 4 hours) will be eligible for enrolment in the study.

You may qualify if:

• Signed written consent
• Patients scheduled for non-cardiac surgery (with a duration of 1 to 4 hours)

You may not qualify if:

• Lack of comprehension of the French, English or Dutch language
• Visual or auditory impairment
• Any other reason that makes patients unable to perform cognitive testing

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• CHU de Charleroi: collaborator

Study Sites (1)

CHU-Charleroi Hopital Civil Marie Curie

Charleroi, Hainaut, Belgium

Location

Related Publications (1)

• Saxena S, Rodts C, Nuyens V, Lazaron J, Sosnowski V, Verdonk F, Seidel L, Albert A, Boogaerts J, Kruys V, Maze M, Vamecq J. Preoperative sedentary behavior is neither a risk factor for perioperative neurocognitive disorders nor associated with an increase in peripheral inflammation, a prospective observational cohort study. BMC Anesthesiol. 2020 Nov 14;20(1):284. doi: 10.1186/s12871-020-01200-w.

  PMID: 33187477 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample (as usual)

Study Officials

• Jean Boogaerts, MD; PhD

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist; Principal Investigator

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: January 16, 2019
• Study Start: February 3, 2019
• Primary Completion: September 25, 2019
• Study Completion: October 30, 2019
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

BE (1)