An Observational Study on the Relationship Between Tear Metabolomics and POD

Postoperative Delirium Clinical Trial

Official title:

An Observational Study on the Relationship Between Tear Metabolomics and POD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548153
• Other study ID #: tear and delirium
• Status: Completed
• Start date: August 22, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore the correlation between tear metabolomics and POD. The purpose of this study was to compare the results of tear metabolomics between POD and non-POD elderly patients undergoing abdominal surgery, to clarify the correlation between tear metabolomics and POD, and to find tear markers related to POD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 65-90 years old;

• ASA I-III;

• patients who plan to undergo elective abdominal surgery under general anesthesia;

• Volunteer to participate in this study and sign informed consent.

Exclusion Criteria:

• patients with known mental illness or lack of communication or cognitive impairment before operation;

• severe vision, hearing, language impairment or other reasons unable to communicate with visitors;

• severe dysfunction of important organs such as heart, brain, lung, liver, kidney, etc.;

• long-term use of sedatives, antidepressants or alcoholism;

• patients with severe postoperative complications and admitted to intensive care unit;

• patients who refused or failed to complete the cognitive function test.

• patients who could not cooperate with the study for any other reason

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative delirium during the 3 adys-follow-up after anesthetic resuscitation	Postoperative delirium was tested with 3D-Confusion Assessment Method or Confusion Assessment Method-intensive care unit (0-4, higher scores means worse). The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.	From ending of the surgery to 3 days after anesthetic resuscitation
Secondary	Postoperative delirium in the postanesthesia care unit	Postoperative delirium was tested with Confusion Assessment Method-intensive care unit. Postoperative delirium was tested with Confusion Assessment Method-intensive care unit (0-4, higher scores means worse outcome). The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.	From ending of the surgery to the time when discharge from postanesthesia care unit, an average of 30 minutes.
Secondary	Postoperative delirium on the first day after operation	Postoperative delirium was tested with 3D-Confusion Assessment Method (0-4, higher scores means worse outcome). The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.	9:00-10:00 and 15:00-16:00 on The first day after operation
Secondary	Postoperative delirium on the second day after operation	Postoperative delirium was tested with 3D-Confusion Assessment Method (0-4, higher scores means worse outcome). The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.	9:00-10:00 and 15:00-16:00 on The second day after operation
Secondary	Postoperative delirium on the third day after operation	Postoperative delirium was tested with 3D-Confusion Assessment Method (0-4, higher scores means worse outcome). The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.	9:00-10:00 and 15:00-16:00 on The third day after operation