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

NCT05694091 | Unknown

• 1 other identifier: SH9H-2022-T331-1
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium in Old Age

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• MOCA(Montreal Cognitive Assessment) scale

  1 day after surgery

• MOCA(Montreal Cognitive Assessment) scale

  3 day after surgery

• MOCA(Montreal Cognitive Assessment) scale

  7 day after surgery

• MMSE (mini-mental state examiniation) scale

  1 day after surgery

• MMSE (mini-mental state examiniation) scale

  3 day after surgery

Study Arms (2)

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

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

Interventions

Collecting clinical data, blood gas data, Magnetic Resonance Spectroscopy (MRS) data and blood,urine, and feces sample OTHER

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.; Patients in the control group were followed up without delirium postoperatively.

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• The ASA grade of the subject is Ⅰ - Ⅲ;
• years old;
• Oral craniomaxillofacial surgery under combined general anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai 9Th Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection; Urination

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Hong Jiang, Doctor

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

  STUDY DIRECTOR

Central Study Contacts

Ren Zhou, PhD

CONTACT

15121007303; zhouren77@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: November 18, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 6, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)