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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Cognitive Dysfunction

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Han Yuan

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 10, 2016
• First Posted (ESTIMATE): December 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: non-cardiac surgery; Postoperative Cognitive Dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: XYFY2016-KL018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: within six months after the trial complete