An Observational Study on the Relationship Between Tear Metabolomics and POD

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Director: Huang He, MD, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: tear and delirium

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No