Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394778
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-29
Brief Title:
Electroencephalogram Characteristics of Surgical Anesthetized Patients and Postoperative Dilirium
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
First Affiliated Hospital of Zhejiang University
Study Overview
Official Title:
Electroencephalogram Characteristics of Surgical Anesthetized Patients and Their Correlation With Postoperative Delirium
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PurposeConstruct 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 ContentThis 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 1300 and 2000 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 patientsResearch significanceThe 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
Detailed 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 1300 and 2000 on the day before surgery
Postoperative delirium assessment
During the PACU period after surgery the score was calculated based on the CAM-ICU scale evaluationDuring the first 5 days after surgery patients undergo an evaluation via 3D-CAM between 1300 and 2000 every day or at any time when they experience significant delirium symptoms unless they are discharged or taking sedatives RASS -3
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 1300 and 2000 on the day before surgery
Postoperative delirium assessment
During the PACU period after surgery the score was calculated based on the CAM-ICU scale evaluationDuring the first 5 days after surgery patients undergo an evaluation via 3D-CAM between 1300 and 2000 every day or at any time when they experience significant delirium symptoms unless they are discharged or taking sedatives RASS -3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None