Clinical trial NCT05694091: Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients
Official title: Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delirium in Old Age
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
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 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.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
timeFrame: 1 day after surgery
measure: 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
timeFrame: 2 day after surgery
measure: 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
timeFrame: 3 day after surgery
measure: 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
timeFrame: 4 day after surgery
measure: 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
timeFrame: 5 day after surgery
measure: 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
timeFrame: 6 day after surgery
measure: 3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale
timeFrame: 7 day after surgery
Secondary outcomes:
measure: MOCA(Montreal Cognitive Assessment) scale
timeFrame: 1 day after surgery
measure: MOCA(Montreal Cognitive Assessment) scale
timeFrame: 3 day after surgery
measure: MOCA(Montreal Cognitive Assessment) scale
timeFrame: 7 day after surgery
measure: MMSE (mini-mental state examiniation) scale
timeFrame: 1 day after surgery
measure: MMSE (mini-mental state examiniation) scale
timeFrame: 3 day after surgery
measure: MMSE (mini-mental state examiniation) scale
timeFrame: 7 day after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 9Th Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Hong Jiang, Doctor
role: STUDY_DIRECTOR
References: