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

Delirium in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694091
• Other study ID #: SH9H-2022-T331-1
• Status: Recruiting
• Start date: November 18, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Ren Zhou, PhD
• Phone: 15121007303
• Email: zhouren77[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• The ASA grade of the subject is ? - ?;

• 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.

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age
• Emergence Delirium

Intervention

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)

Locations

Country	Name	City	State
China	Shanghai 9Th Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	1 day after surgery
Primary	3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	2 day after surgery
Primary	3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	3 day after surgery
Primary	3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	4 day after surgery
Primary	3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	5 day after surgery
Primary	3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	6 day after surgery
Primary	3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale	3D-CAM higher means worse	7 day after surgery
Secondary	MOCA(Montreal Cognitive Assessment) scale	MOCA higher means better	1 day after surgery
Secondary	MOCA(Montreal Cognitive Assessment) scale	MOCA higher means better	3 day after surgery
Secondary	MOCA(Montreal Cognitive Assessment) scale	MOCA higher means better	7 day after surgery
Secondary	MMSE (mini-mental state examiniation) scale	MMSE higher means better	1 day after surgery
Secondary	MMSE (mini-mental state examiniation) scale	MMSE higher means better	3 day after surgery
Secondary	MMSE (mini-mental state examiniation) scale	MMSE higher means better	7 day after surgery