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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05105451
Enrollment
80
Registered
2021-11-03
Start date
2021-05-22
Completion date
2026-12-30
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Neurocognitive Recovery

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.

Interventions

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

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)

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
MMSE (mini-mental state examiniation)1 day after surgeryMMSE 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.
MOCA (Montreal Cognitive Assessment)1 day after surgeryMOCA 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.
T-MoCA (The telephone MoCA)15 day after surgeryMOCA 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

MeasureTime frameDescription
3D-CAM1 day after surgery3D-CAM score
Self-Rating Anxiety Scaleright before surgerySelf-Rating Anxiety Scale score
Self-rating depression scaleright before surgerySelf-rating depression scale score

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 23, 2026