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

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992600
• Other study ID #: XYFY2016-KL018-01
• Status: Completed
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2022
• Source: Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
China	Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Han Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the neuropsychological test battery to measure cognitive function		1 day before surgery(baseline)
Primary	olfaction test to measure the sense of smell		1 day before surgery(baseline)
Primary	the neuropsychological tests to measure cognitive function		within 5 to 10 days (average of 7 days) after surgery
Primary	olfaction test to measure the sense of smell		within 5 to 10 days (average of 7 days) after surgery