Clinical Trials Logo

Clinical Trial Summary

Purpose:Construct a perioperative EEG database for elderly patients under general anesthesia, and explore the correlation between their EEG spectrum characteristics and the occurrence and severity of postoperative delirium. Content:This study aims to investigate patients undergoing elective orthopedic surgery, analyze the changes in perioperative EEG spectrum, correlate with the occurrence and severity of POD, and explore the relationship between perioperative EEG changes and the development of postoperative delirium. Method: Patients aged over 60 years old who are scheduled for orthopedic surgery and plan to stay in hospital for more than two days were selected. All patients underwent preoperative MMSE and 3D-CAM assessments. Subsequently, anesthetic depth monitor electrodes were applied to the occipital or frontal-temporal regions of the patient to collect electroencephalograms of the occipital lobe during conscious and quiet states, the frontal lobe during general anesthesia, and the recovery room. During PACU, scores were calculated based on the CAM-ICU scale evaluation. During the first 5 days after surgery, patients were evaluated every day between 13:00 and 20:00 using 3D-CAM, or at any time when they showed obvious symptoms of delirium, unless they were discharged or taking sedatives (RASS < -3). Ten minutes after the end of the evaluation, patients' electroencephalograms were monitored in a conscious and quiet state, or in a state of obvious delirium. Patients were divided into a delirium group and a non-delirium group based on whether they developed delirium after surgery. The characteristics of electroencephalograms before, during, and after surgery were analyzed in both groups of patients.Research significance:The results of this study may provide objective indicators and theoretical basis for monitoring and diagnosing the occurrence and development of POD, which can help clinical doctors identify patients with increased delirium risk in the early stage, and adjust the plan in a timely manner to change the triggering risk factors of POD.


Clinical Trial Description

Preoperative cognitive and delirium assessment: The MMSE scale assesses patients' 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 the actual situation in China and previous research, we set the criteria for illiteracy or most primary and junior high school subjects as ≤17, ≤20, and ≤24, respectively. Individuals with scores lower than the corresponding criteria are considered to have preoperative cognitive impairment. Preoperative baseline values for 3D-CAM assessment of delirium status: Patients were assessed for delirium using the 3-minute Rapid Confusion Assessment Method (3D-CAM) between 13:00 and 20:00 on the day before surgery. Postoperative delirium assessment: During the PACU period after surgery, the score was calculated based on the CAM-ICU scale evaluation;During the first 5 days after surgery, patients undergo an evaluation via 3D-CAM between 13:00 and 20:00 every day, or at any time when they experience significant delirium symptoms, unless they are discharged or taking sedatives (RASS < -3). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06394778
Study type Observational
Source First Affiliated Hospital of Zhejiang University
Contact Shuyuan Gan, Doctor
Phone 13600527369
Email ganshuyuan@163.com
Status Not yet recruiting
Phase
Start date April 22, 2024
Completion date April 15, 2027

See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT05891873 - Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Recruiting NCT06194474 - Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
Completed NCT03095417 - Improving the Recovery and Outcome Every Day After the ICU N/A
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Not yet recruiting NCT04846023 - Pediatric Delirium Screening in the PICU Via EEG N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Withdrawn NCT02673450 - PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
Recruiting NCT03256500 - Transcranial Direct Current Stimulation for the Treatment of Delirium N/A
Completed NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Recruiting NCT03165539 - Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
Completed NCT02554253 - The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction Phase 2
Completed NCT02518646 - DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models N/A
Recruiting NCT02305589 - The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium N/A
Completed NCT02628925 - Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale N/A