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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Delayed Neurocognitive Recovery
• Intervention / Treatment: Other: Collecting clinical data, EGG，arterial blood gas data and venous blood sample

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai 9Th Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Our research is a single center, nested case-control study. Preoperatively collect the information of the elderly patients over 65 years old without undergoing craniocerebral operations, including the vital signs, the examination reports and other related data after excluding the factors that can't be included in the group. The patients' health scales and dNCR. scales were evaluated.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients in the control group were followed up without dNCR postoperatively.; If the MOCA or MMSE assessment all show a negative resluts at all time point.	Other: Collecting 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）
Patients in the case group were followed up with dNCR postoperatively.; 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.	Other: Collecting 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）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMSE (mini-mental state examiniation)	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 dNCR.	1 day after surgery
MOCA (Montreal Cognitive Assessment)	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.	1 day after surgery
MMSE (mini-mental state examiniation)	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 dNCR.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.	3 day after surgery
MOCA (Montreal Cognitive Assessment)	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.	3 day after surgery
MMSE (mini-mental state examiniation)	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 dNCR. 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.	7 day after surgery
MOCA (Montreal Cognitive Assessment)	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.	7 day after surgery
MOCA (Montreal Cognitive Assessment)	MOCA sacle score,baseline	right before surgery
MMSE (mini-mental state examiniation)	MMSE scale score, baseline	right before surgery
T-MoCA (The telephone MoCA)	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.	15 day after surgery
T-MoCA (The telephone MoCA)	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.	30 day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D-CAM	3D-CAM score	1 day after surgery
Self-Rating Anxiety Scale	Self-Rating Anxiety Scale score	right before surgery
Self-rating depression scale	Self-rating depression scale score	right before surgery

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Study Director: Hong Jiang, Doctor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 16, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SH9H-2021-T120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No