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

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 65~90 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.

Study Overview

• Status: Recruiting
• Conditions: Delirium in Old Age
• Intervention / Treatment: Other: Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sample

• Study Type: Observational
• Enrollment (Estimated): 46

Contacts and Locations

• Study Contact: Name: Ren Zhou, PhD; Phone Number: 15121007303; Email: zhouren77@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai 9Th Hospital
      • Contact: Hong Jiang; Email: jianghongjiuyuan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No

• 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 65-90 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 delirium scales were evaluated.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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,urine, and feces 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,urine, and feces 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,urine, and feces 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,urine, and feces sample （before induction of anesthesia and first day, third day and 7th day after surgery）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	1 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	2 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	3 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	4 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	5 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	6 day after surgery
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	7 day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MOCA(Montreal Cognitive Assessment) scale	MOCA higher means better	1 day after surgery
MOCA(Montreal Cognitive Assessment) scale	MOCA higher means better	3 day after surgery
MOCA(Montreal Cognitive Assessment) scale	MOCA higher means better	7 day after surgery
MMSE (mini-mental state examiniation) scale	MMSE higher means better	1 day after surgery
MMSE (mini-mental state examiniation) scale	MMSE higher means better	3 day after surgery
MMSE (mini-mental state examiniation) scale	MMSE higher means better	7 day after surgery

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: SH9H-2022-T331-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No