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NCT Number: NCT05105451

Study on the Characteristics of Non-targeted Metabolomics and EEG of Delayed Neurocognitive Recovery in Elderly Patients

Perioperative neurocognitive disorder (PND) refers to a broad range of postoperative cognitive complications, including preoperatively diagnosed cognitive decline, postoperative delirium (POD), delayed neurocognitive recovery (dNCR), and neurocognitive disorders . Among them, dNCR refers to a decline in cognitive function that occurs approximately 1-4 weeks after anesthesia/surgery in elderly patients. It is associated with an increased risk of postoperative complications and an increased length of hospital stay.

The identification of potential predictive biomarkers would be beneficial for determining the individual risk of developing dNCR and for postoperative management of elderly patients. Although some predictive markers for PNDs, such as inflammatory factors, tau protein, S100B protein, neuron-specific enolase, and brain-derived neurotrophic factor, are widely known, most of them are postoperative predictive markers. The markers that can be used to predict PNDs before anesthesia/surgery are still largely unknown.

Preoperative markers allow us to identify individuals who are susceptible to dNCR and intervene early. It is unclear whether the metabolic status of preoperative patients is related to the occurrence of postoperative cognitive dysfunction (POCD). In the framework of systems biology based on genome, transcriptome, proteome, and metabolome, metabolomics is the closest to biological phenotypes because it reflects biological events that have occurred in living organisms. Considering that metabolome reflects the metabolites of all biochemical reactions that have already taken place in an organism and contains a huge amount of information about an organism's health, preoperative patient metabolites may be a useful predictive biomarker. In this study, we used serum metabolomics to develop non-invasive, easily detectable, and inexpensive preoperative biomarkers from patient blood to determine the individual risk of dNCR and the relationship between metabolic system abnormalities and the pathogenesis of dNCR.

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Key information

Conditions

Delayed Neurocognitive Recovery

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai 9Th Hospital

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Gender: no gender limit
  • 65 years or older .
  • Complete the operation in our hospital
  • ASA classification I-II level
  • Agree to participate in this research and agree to sign an informed consent form

Exclusion criteria

  • History of preoperative psychosis and psychotropic drug use
  • The subject is diagnosed with AD;
  • Abnormal preoperative mental scale assessment
  • Have a history of emergency rescue during the perioperative period

Treatment and study plan

Collecting clinical data, EGG，arterial blood gas data and venous blood sample

Other

Collecting clinical data(before induction of anesthesia and first day after surgery), EGG（first day after surgery），arterial blood gas data(before induction of anesthesia and first day after surgery) and venous blood sample （before induction of anesthesia and first day, third day and 7th day after surgery）

Primary outcomes

  1. MMSE (mini-mental state examiniation)

    Time frame: 1 day after surgery

    MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

  2. MOCA (Montreal Cognitive Assessment)

    Time frame: 1 day after surgery

    MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

  3. MMSE (mini-mental state examiniation)

    Time frame: 3 day after surgery

    MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

  4. MOCA (Montreal Cognitive Assessment)

    Time frame: 3 day after surgery

    MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

  5. MMSE (mini-mental state examiniation)

    Time frame: 7 day after surgery

    MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR. a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

  6. MOCA (Montreal Cognitive Assessment)

    Time frame: 7 day after surgery

    MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

  7. MOCA (Montreal Cognitive Assessment)

    Time frame: right before surgery

    MOCA sacle score,baseline

  8. MMSE (mini-mental state examiniation)

    Time frame: right before surgery

    MMSE scale score, baseline

  9. T-MoCA (The telephone MoCA)

    Time frame: 15 day after surgery

    MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

  10. T-MoCA (The telephone MoCA)

    Time frame: 30 day after surgery

    MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

Secondary outcomes

  1. 3D-CAM

    Time frame: 1 day after surgery

    3D-CAM score

  2. Self-Rating Anxiety Scale

    Time frame: right before surgery

    Self-Rating Anxiety Scale score

  3. Self-rating depression scale

    Time frame: right before surgery

    Self-rating depression scale score

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 3, 2021
Registry last updated
Jul 18, 2023

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

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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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