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NCT Number: NCT05555693

Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients

Postoperative cognitive dysfunction (POCD) refers to the difficulties of orientation, cognition, communication, memory and abstract thinking of patients after anesthesia and surgery. And/or accompanied by the decline of the ability in social activities, such as the change of personality, social ability of language and behavior, cognitive function and life skills. POCD is a common complication of central nervous system in elderly patients after operation, with an early incidence of about 21% and a long-term incidence of about 35% . According to the current research on Alzheimer's disease (AD) and POCD in the elderly, it has been found that they have similar pathological basis and some homologous related genes. Altogether, POCD is closely related to molecular pathway neuropsychiatric diseases (such as dementia, depression and Alzheimer's disease). Researchers have come up with various hypotheses to reveal the underlying mechanisms of POCD, including neuritis, oxidative stress, autophagy disorder, synaptic dysfunction, and lack of neurotrophic support. To date, apart from evaluating with scales, CT Scan and EEG analysis, there is neither exact biomarkers for monitoring and diagnosing POCD, nor clear relationships between specific Brain Metabolomic Characteristics, EEG changes and diagnosis of POCD, so that the diagnosis of early POCD only stays in the evaluation of clinical symptoms and scales. Therefore, our study aims to provide an effective basis for early diagnosis and treatment of clinical POCD through multivariate analyses of clinical scales combined with Brain Metabolomic Characteristics, EEG analysis of patients.

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Key information

Conditions

POCD - Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai 9Th Hospital

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Hong Jiang

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • metal implants
  • Postoperative immobilization patients

Treatment and study plan

Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample

Other

Collecting clinical data(before induction of anesthesia and first day after surgery), EGG（first day after surgery），Magnetic Resonance Spectroscopy data (before induction of anesthesia and first day after surgery)blood gas data(before induction of anesthesia and first day after surgery) and 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 POCD.

  2. MMSE (mini-mental state examiniation)

    Time frame: immediately before 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 POCD.

  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 POCD.

  4. 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 POCD.

  5. 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 POCD.

  6. 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 POCD.

  7. 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 POCD.

  8. MOCA (Montreal Cognitive Assessment)

    Time frame: immediately before 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 POCD.

Secondary outcomes

  1. 3D-CAM

    Time frame: 1 day after surgery

    3D-CAM score

  2. Self-Rating Anxiety Scale

    Time frame: immediately before surgery

    Self-Rating Anxiety Scale score

  3. Self-rating depression scale

    Time frame: immediately before surgery

    Self-rating depression scale score

Study contacts

Contact information is provided by the study sponsor or research team.

Ren Zhou, PhD

CONTACT

[email protected]

15121007303

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 27, 2022
Registry last updated
Sep 27, 2022

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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