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

Active, not recruiting

• Conditions: Delayed Neurocognitive Recovery
• Interventions: Other: Collecting clinical data, EGG，arterial blood gas data and venous blood sample

• Registration Number: NCT05105451
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-22
• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-11-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-16
• Last Update Posted: 2023-07-18
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients in the control group were followed up without dNCR postoperatively.	Collecting clinical data, EGG，arterial blood gas data and venous blood sample	If the MOCA or MMSE assessment all show a negative resluts at all time point.
Patients in the case group were followed up with dNCR postoperatively.	Collecting clinical data, EGG，arterial blood gas data and venous blood sample	If the MOCA assessment is positive at any time point after surgery, and there is a positive MMSE at any time point after surgery(no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

Primary Outcome Measures

Name	Time	Method
T-MoCA (The telephone MoCA)	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)	right before surgery	MOCA sacle score,baseline
MMSE (mini-mental state examiniation)	right before surgery	MMSE scale score, baseline

Secondary Outcome Measures

Name	Time	Method
Self-rating depression scale	right before surgery	Self-rating depression scale score
3D-CAM	1 day after surgery	3D-CAM score
Self-Rating Anxiety Scale	right before surgery	Self-Rating Anxiety Scale score

Trial Locations

Locations (1)

Shanghai 9Th Hospital; 🇨🇳 Shanghai, Shanghai, China