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Completed

NCT Number: NCT05548153

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.

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Key information

Conditions

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

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative delirium during the 3 adys-follow-up after anesthetic resuscitation

    Time frame: 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 outcomes

  1. Postoperative delirium in the postanesthesia care unit

    Time frame: 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.

  2. Postoperative delirium on the first day after operation

    Time frame: 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.

  3. Postoperative delirium on the second day after operation

    Time frame: 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.

  4. Postoperative delirium on the third day after operation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2022
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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