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Clinical Trials/NCT05555693
NCT05555693
Recruiting
Not Applicable

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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country200 target enrollmentJuly 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
POCD - Postoperative Cognitive Dysfunction
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment
200
Locations
1
Primary Endpoint
MMSE (mini-mental state examiniation)
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 27, 2022
End Date
December 1, 2027
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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

  • 3D-CAM(1 day after surgery)
  • Self-Rating Anxiety Scale(immediately before surgery)
  • Self-rating depression scale(immediately before surgery)

Study Sites (1)

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