🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06394778
Enrolling by invitation Observational

Electroencephalogram Characteristics of Surgical Anesthetized Patients and Postoperative Dilirium

NCT06394778 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Zhejiang University
Phase
Observational
Started
2024-05-13
Last updated
2026-01-12

Condition(s) studied

ElectroencephalogramPostoperative Delirium (POD)

Investigational drug(s) / intervention(s)

Delirium test scale:3D-CAM

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.

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Patients aged ≥ 60 years, scheduled for orthopedic joint replacement or spinal surgery, ASA grade I-III, expected surgery time ≥ 2 hours, and able to provide written informed consent. Exclusion Criteria: 1. Patients with central nervous system diseases or mental disorders; 2. patients with severe systemic diseases such as cardiopulmonary, liver and kidney dysfunction, coagulation dysfunction, etc.; 3. patients who frequently use psychotropic drugs, opioids or corticosteroids; 4. patients with a history of intraoperative awareness; 5. patients who are unable to complete preoperative delirium screening due to severe blindness, deafness, illiteracy or Mandarin speaking; 6. patients who are expected to undergo a second operation within 7 days.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, Zhejiang University, School of Medicine Hangzhou Zhejiang

More First Affiliated Hospital of Zhejiang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06394778 on ClinicalTrials.gov ↗ ← All trials in China