An Observational Study on the Relationship Between Tear Metabolomics and POD

Completed

• Conditions: Postoperative Delirium

• Registration Number: NCT05548153
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-22
• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-21
• Status Verified: 2022-12
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative delirium during the 3 adys-follow-up after anesthetic resuscitation	From ending of the surgery to 3 days 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.

Secondary Outcome Measures

Name	Time	Method
Postoperative delirium on the first day after operation	9：00-10：00 and 15：00-16：00 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.
Postoperative delirium on the second day after operation	9：00-10：00 and 15：00-16：00 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.
Postoperative delirium on the third day after operation	9：00-10：00 and 15：00-16：00 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.
Postoperative delirium in the postanesthesia care unit	From ending of the surgery to the time when discharge from postanesthesia care unit, an average of 30 minutes.	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.

Trial Locations

Locations (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China