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

POCD - Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555693
• Other study ID #: SH9H-2022-T133-2
• Status: Recruiting
• Start date: July 27, 2022
• Est. completion date: December 1, 2027

Study information

• Verified date: September 2022
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Ren Zhou, PhD
• Phone: 15121007303
• Email: zhouren77[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• POCD - Postoperative Cognitive Dysfunction
• Postoperative Cognitive Complications

Intervention

Other:
• Collecting clinical data, EGG,Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample
Collecting clinical data(before induction of anesthesia and first day after surgery), EGG(first day after surgery),Magnetic Resonance Spectroscopy data (before induction of anesthesia and first day after surgery)blood gas data(before induction of anesthesia and first day after surgery) and blood sample (before induction of anesthesia and first day, third day and 7th day after surgery)

Locations

Country	Name	City	State
China	Shanghai 9Th Hospital	Shanghai	Shanghai

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 POCD.	1 day after surgery
Primary	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 POCD.	immediately before surgery
Primary	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 POCD.	3 day after surgery
Primary	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 POCD.	7 day after surgery
Primary	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 POCD.	1 day after surgery
Primary	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 POCD.	3 day after surgery
Primary	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 POCD.	7 day after surgery
Primary	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 POCD.	immediately before surgery
Secondary	3D-CAM	3D-CAM score	1 day after surgery
Secondary	Self-Rating Anxiety Scale	Self-Rating Anxiety Scale score	immediately before surgery
Secondary	Self-rating depression scale	Self-rating depression scale score	immediately before surgery