An Observational Study on the Relationship Between Tear Metabolomics and POD

NCT05548153 | Completed

• 1 other identifier: tear and delirium
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 on the first day after operation

  9：00-10：00 and 15：00-16：00 on The first day after operation

• 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 on the third day after operation

  9：00-10：00 and 15：00-16：00 on The third day after operation

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In the elderly patients who underwent abdominal surgery under general anesthesia, there were no serious systemic diseases and severe cognitive impairment before operation.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tear was collected

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Huang He, MD

  Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 21, 2022
• Study Start: August 22, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 29, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)