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ENROLLING BY INVITATION
NCT06394778

Electroencephalogram Characteristics of Surgical Anesthetized Patients and Postoperative Dilirium

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

Objective: To construct a perioperative EEG database for elderly patients under general anesthesia and to explore the relationship between their EEG spectrum characteristics and the occurrence and severity of postoperative delirium. Content: This study aims to investigate elderly patients undergoing elective orthopedic surgery under general anesthesia with endotracheal intubation, analyze the changes in the perioperative EEG spectrum and its correlation with the occurrence of postoperative delirium, and explore the relationship between perioperative EEG changes and the occurrence of postoperative delirium. Methods: Patients aged 60 years or older who were scheduled to undergo orthopedic joint replacement or spinal surgery and had a hospital stay of more than 2 days were selected. All patients underwent MMSE and 3D-CAM assessment before surgery. Before anesthesia induction, anesthesia depth monitoring electrodes were placed on the patient\'s occipital or frontal temporal region, and EEGs were collected in awake and quiet states, under general anesthesia, and during anesthesia recovery. In the PACU, the score was calculated based on the CAM-ICU scale. The patients were assessed with the 3D-CAM scale for awakening once a day at 15:00-20:00 the day before surgery, and twice a day at 9:00-11:00 and 15:00-20:00 during 1-5 days after surgery, or at any time when obvious delirium symptoms appeared, unless discharged from the hospital or taking sedatives (RASS\<-3). Ten minutes after the assessment, the occipital EEG was monitored when the patient was conscious and quiet, or when obvious delirium appeared. According to the test results of the 3D-CAM scale, it was determined whether the patient had postoperative delirium, and the patients were divided into the delirium group and the non-delirium group. The EEG characteristics of the two groups of patients were analyzed before, during, and after surgery. Research significance: The results of this study can provide objective indicators and theoretical basis for monitoring and diagnosing the occurrence and development of POD, which can help clinicians to identify patients with increased risk of delirium at an early stage, adjust the plan in time, and change the triggering risk factors of POD.

Official title: Electroencephalogram Characteristics of Surgical Anesthetized Patients and Their Correlation With Postoperative Delirium

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

OBSERVATIONAL

Enrollment

375

Start Date

2024-05-13

Completion Date

2027-04-15

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Delirium test scale:3D-CAM

The 3D-CAM is a 3-minute delirium assessment that is also based upon the CAM algorithm and has four features: (1) altered mental status/fluctuating course, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking.

Locations (1)

The First Affiliated Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China