Study on the Characteristics of Non-targeted Metabolomics and EEG of Postoperative Cognitive Dysfunction in Elderly Patients

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05105451
Collaborator
(none)
200
1
67.3
3

Study Details

Study Description

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 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 EEG analysis of patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Collecting clinical data, EGG,blood gas data and blood sample

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study on the Characteristics of Non-targeted Metabolomics and EEG of Postoperative Cognitive Dysfunction in Elderly Patients
Actual Study Start Date :
May 22, 2021
Anticipated Primary Completion Date :
Dec 30, 2026
Anticipated Study Completion Date :
Dec 30, 2026

Arms and Interventions

Arm Intervention/Treatment
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,blood gas data and blood sample
Collecting clinical data(before induction of anesthesia and first day after surgery), EGG(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.

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 POCD.

Other: Collecting clinical data, EGG,blood gas data and blood sample
Collecting clinical data(before induction of anesthesia and first day after surgery), EGG(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)

Outcome Measures

Primary Outcome Measures

  1. MMSE (mini-mental state examiniation) [1 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.

  2. MOCA (Montreal Cognitive Assessment) [1 day after 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.

  3. MMSE (mini-mental state examiniation) [3 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.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.

  4. MOCA (Montreal Cognitive Assessment) [3 day after 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.

  5. 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.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.

  6. MOCA (Montreal Cognitive Assessment) [7 day after 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.

  7. MOCA (Montreal Cognitive Assessment) [right before surgery]

    MOCA sacle score,baseline

  8. MMSE (mini-mental state examiniation) [right before surgery]

    MMSE scale score, baseline

Secondary Outcome Measures

  1. 3D-CAM [1 day after surgery]

    3D-CAM score

  2. Self-Rating Anxiety Scale [right before surgery]

    Self-Rating Anxiety Scale score

  3. Self-rating depression scale [right before surgery]

    Self-rating depression scale score

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai 9Th Hospital Shanghai Shanghai China 200000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier:
NCT05105451
Other Study ID Numbers:
  • SH9H-2021-T120
First Posted:
Nov 3, 2021
Last Update Posted:
Aug 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022