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

Recruiting

• Conditions: POCD - Postoperative Cognitive Dysfunction
• Interventions: Other: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample

• Registration Number: NCT05555693
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-27
• Status Verified: 2022-09
• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Study First Posted: 2022-09-27
• Last Update Posted: 2022-09-27
• Primary Completion: 2027-01-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients in the case group were followed up with POCD postoperatively.	Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and 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
Patients in the control group were followed up without POCD postoperatively.	Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample	If the MOCA or MMSE assessment all show a negative resluts at all time point.

Primary Outcome Measures

Name	Time	Method
MMSE (mini-mental state examiniation)	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)	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 Outcome Measures

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

Trial Locations

Locations (1)

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