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Clinical Trials/NCT05105451
NCT05105451
Active, not recruiting
Not Applicable

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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country80 target enrollmentMay 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delayed Neurocognitive Recovery
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment
80
Locations
1
Primary Endpoint
T-MoCA (The telephone MoCA)
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 22, 2021
End Date
December 30, 2026
Last Updated
2 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

  • 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

Outcomes

Primary Outcomes

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.

MOCA (Montreal Cognitive Assessment)

Time Frame: right before surgery

MOCA sacle score,baseline

MMSE (mini-mental state examiniation)

Time Frame: right before surgery

MMSE scale score, baseline

Secondary Outcomes

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

Study Sites (1)

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