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NCT Number: NCT06394778

Electroencephalogram Characteristics of Surgical Anesthetized Patients and Postoperative Dilirium

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310003, China

About this study

Preoperative cognitive and delirium assessment:

MMSE scale assesses the patient's preoperative cognitive function status: the total score is 30 points, the higher the score, the better the cognitive function. Considering the impact of education level on MMSE assessment, combined with my country's actual situation and previous studies, we set the assessment criteria for illiterate or most primary and junior high school education levels to ≤17, ≤20, and ≤24, respectively. Individuals below the corresponding standards are considered to have cognitive impairment before surgery.

Preoperative 3D-CAM baseline value for delirium assessment: patients were assessed for delirium using the 3-minute rapid mental confusion assessment method (3D-CAM) between 15:00 and 20:00 the day before surgery.

Postoperative delirium assessment:

During the postoperative PACU period, the score was calculated based on the CAM-ICU scale; 1-5 days after surgery, patients underwent 3D-CAM assessment twice a day at 9:00-11:00 and 15:00-20:00, or at any time when obvious delirium symptoms appeared, unless discharged or taking sedatives (RASS<-3).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients with central nervous system diseases or mental disorders;
  • patients with severe systemic diseases such as cardiopulmonary, liver and kidney dysfunction, coagulation dysfunction, etc.;
  • patients who frequently use psychotropic drugs, opioids or corticosteroids;
  • patients with a history of intraoperative awareness;
  • patients who are unable to complete preoperative delirium screening due to severe blindness, deafness, illiteracy or Mandarin speaking;
  • patients who are expected to undergo a second operation within 7 days.

Treatment and study plan

Delirium test scale:3D-CAM

Diagnostic Test

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.

Primary outcomes

  1. Correlation between perioperative EEG spectral changes and postoperative delirium

    Time frame: 2 years

    Characteristic changes of EEG spectral changes in patients with POD before, during, and after surgery

  2. Incidence of POD

    Time frame: 1 years

    The proportion of POD occurrence

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 1, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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