Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes

NCT02992600 | Completed

• 1 other identifier: XYFY2016-KL018-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a predictor of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.

Conditions

Postoperative Cognitive Dysfunction

Keywords

non-cardiac surgery; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (4)

• the neuropsychological test battery to measure cognitive function

  1 day before surgery(baseline)

• olfaction test to measure the sense of smell

  1 day before surgery(baseline)

• the neuropsychological tests to measure cognitive function

  within 5 to 10 days (average of 7 days) after surgery

• olfaction test to measure the sense of smell

  within 5 to 10 days (average of 7 days) after surgery

Study Arms (2)

study group

300 male and female patients undergoing non-cardiac surgery are enrolled at the Affiliated Hospital of Xuzhou Medical University \[Jiangsu China\]. Patients will be divided into POCD and non-POCD groups according to the scores of neuropsychological tests.

control group

30 healthy volunteers are enrolled for calculating the Z-scores of study group.

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We included 300 male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University and 30 healthy volunteers.

You may qualify if:

• Between 60 to 85 years old;
• Undergoing non-cardiac and non-neurological surgery under general anesthesia;
• Expected hospital stay ≥5 days;
• American Society of Anesthesiologists class I or II.

You may not qualify if:

• Mental or neurodegenerative diseases;
• History of severe trauma or surgery within one year;
• History of nasal or sinus illness or surgery;
• Cold or influenza within 3 weeks;
• Significant history of organ dysfunction;
• Previous neuropsychological testing;
• Difficulty to perform tests (including severe visual or auditory disorders);
• Mini-Mental State Examination (MMSE) \<24 points, \<20 points if the participant only attended elementary school, or \<17 points if the participant did not go to school.

Sponsors & Collaborators

• Han Yuan: lead

Study Sites (1)

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician in Anesthesiology

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)