Clinical trial NCT05555693: Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients
Official title: Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: POCD - Postoperative Cognitive Dysfunction
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 preoperative cognitive function scales were evaluated.

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.


Eligibility criteria: 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

Primary outcomes:
measure: MMSE (mini-mental state examiniation)
timeFrame: 1 day after surgery
measure: MMSE (mini-mental state examiniation)
timeFrame: immediately before surgery
measure: MMSE (mini-mental state examiniation)
timeFrame: 3 day after surgery
measure: MMSE (mini-mental state examiniation)
timeFrame: 7 day after surgery
measure: MOCA (Montreal Cognitive Assessment)
timeFrame: 1 day after surgery
measure: MOCA (Montreal Cognitive Assessment)
timeFrame: 3 day after surgery
measure: MOCA (Montreal Cognitive Assessment)
timeFrame: 7 day after surgery
measure: MOCA (Montreal Cognitive Assessment)
timeFrame: immediately before surgery
Secondary outcomes:
measure: 3D-CAM
timeFrame: 1 day after surgery
measure: Self-Rating Anxiety Scale
timeFrame: immediately before surgery
measure: Self-rating depression scale
timeFrame: immediately before surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 9Th Hospital
state: Shanghai
Study officials:
References: