Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06394778 |
| Other study ID # |
IIT20240135B-R1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 22, 2024 |
| Est. completion date |
April 15, 2027 |
Study information
| Verified date |
April 2024 |
| Source |
First Affiliated Hospital of Zhejiang University |
| Contact |
Shuyuan Gan, Doctor |
| Phone |
13600527369 |
| Email |
ganshuyuan[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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).
