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

NCT05555693 | Recruiting

• 1 other identifier: SH9H-2022-T133-2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

POCD - Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• 3D-CAM

  1 day after surgery

• Self-Rating Anxiety Scale

  immediately before surgery

• Self-rating depression scale

  immediately before surgery

Study Arms (2)

Patients in the control group were followed up without POCD postoperatively.

If the MOCA or MMSE assessment all show a negative resluts at all time point.

Other: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample

Patients in the case group were followed up with POCD 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

Other: Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample

Interventions

Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample OTHER

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）

Patients in the case group were followed up with POCD postoperatively.; Patients in the control group were followed up without POCD postoperatively.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai 9Th Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ren Zhou, PhD

CONTACT

15121007303; zhouren77@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: July 27, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)