Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05694091
Collaborator
(none)
46
1
37.4
1.2

Study Details

Study Description

Brief Summary

In view of the increasingly severe aging situation in China, the perioperative brain health of elderly patients has received increasing attention. Postoperative delirium (POD) is a common postoperative complication characterized by acute consciousness and cognitive dysfunction. The incidence of POD in elderly patients undergoing elective non cardiac surgery is 20%45%, which often indicates poor cognitive recovery and becomes a heavy burden for family and society. Although the weight of human brain only accounts for 2% of body weight, the oxygen consumption accounts for 20% of the total oxygen consumption of the whole body. On July 2, 2022, the British Journal of Anaesthesia (Chinese Academy of Sciences Division 1, Anesthesiology Division 1, IF11.719), the top international Journal in the field of anesthesiology, published the scientific research achievements of the first author of the applicant. It was found for the first time that sevoflurane, the most commonly used inhalation anesthetic in clinical practice, can cause the activation of glycolysis and the increase of lactic acid in the brain of elderly non-human primate marmosets, which suggests that general anesthetics will affect brain metabolism in the perioperative period. Therefore, we hypothesized that perioperative changes in brain metabolism might be related to the occurrence of POD in elderly patients. The purpose of this study was to study the relationship between the changes of brain metabolites and POD during perioperative period by noninvasive monitoring of the characteristics of brain tissue metabolites 24 hours before and 24 hours after the operation with hydrogen ion proton magnetic resonance spectroscopy (1-HMRS). In order to complete this purpose, this study plans to collect subjects aged 6590 years who are scheduled to undergo oral and maxillofacial surgery under general anesthesia. The changes of brain metabolites before and after operation were collected by 1-HMRS, and the postoperative delirium related scale was evaluated to analyze the relationship between perioperative changes of brain metabolites and POD.

Condition or Disease Intervention/Treatment Phase
  • Other: Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood sample

Study Design

Study Type:
Observational
Anticipated Enrollment :
46 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients
Actual Study Start Date :
Nov 18, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Patients in the control group were followed up without delirium postoperatively.

If the 3D-CAM scale all show a negative resluts

Other: Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood sample
Collecting clinical data(before induction of anesthesia and first day after surgery), blood gas data(before induction of anesthesia and first day after surgery) ,MRS data (not more than 24h 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 delirium postoperatively.

If the 3D-CAM assessment is positive at any time point after surgery

Other: Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood sample
Collecting clinical data(before induction of anesthesia and first day after surgery), blood gas data(before induction of anesthesia and first day after surgery) ,MRS data (not more than 24h 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. 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) sacle [1 day after surgery]

    3D-CAM higher means worse

  2. 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) sacle [2 day after surgery]

    3D-CAM higher means worse

  3. 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) sacle [3 day after surgery]

    3D-CAM higher means worse

  4. 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) sacle [4 day after surgery]

    3D-CAM higher means worse

  5. 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) sacle [5 day after surgery]

    3D-CAM higher means worse

  6. 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) sacle [6 day after surgery]

    3D-CAM higher means worse

  7. 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) sacle [7 day after surgery]

    3D-CAM higher means worse

Secondary Outcome Measures

  1. MOCA(Montreal Cognitive Assessment) scale [1 day after surgery]

    MOCA higher means better

  2. MOCA(Montreal Cognitive Assessment) scale [3 day after surgery]

    MOCA higher means better

  3. MOCA(Montreal Cognitive Assessment) scale [7 day after surgery]

    MOCA higher means better

  4. MMSE (mini-mental state examiniation) scale [1 day after surgery]

    MMSE higher means better

  5. MMSE (mini-mental state examiniation) scale [3 day after surgery]

    MMSE higher means better

  6. MMSE (mini-mental state examiniation) scale [7 day after surgery]

    MMSE higher means better

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The ASA grade of the subject is Ⅰ - Ⅲ;

  • 65-90 years old;

  • Oral craniomaxillofacial surgery under combined general anesthesia

Exclusion Criteria:
  • The following medical devices have been installed in the body or are to be installed or implanted in the hospital: various cardiac pacemakers; Metal implants (non titanium), ferromagnetic vascular clips in the body

  • The patient is left-handed;

  • Patients with claustrophobia;

  • People with vision and hearing impairment, illiterate or difficult to communicate;

  • The operation plan includes patients with tracheotomy or postoperative catheterization;

  • Refusing to sign the clinical trial consent form.

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

  • Study Director: Hong Jiang, Doctor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier:
NCT05694091
Other Study ID Numbers:
  • SH9H-2022-T331-1
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Nov 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 Jan 23, 2023