Correlation Between Perioperative EEG Features and Delirium After General Anesthesia

Sponsor

Fuzhou Hua (Other)

Overall Status

Recruiting

CT.gov ID

NCT06082024

Collaborator

(none)

Enrollment

Location

13.6

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to compare the perioperative EEG characteristics and the incidence of short-term cognitive dysfunction in patients with postoperative delirium and non-postoperative delirium after elderly (> 65 years old) patients undergoing major gastrointestinal surgery under general anesthesia. The main question it aims to answer are: • The correlation between postoperative cognitive dysfunction and postoperative EEG features was evaluated.• To analyze the correlation between EEG characteristics and clinical risk factors of delirium after major abdominal gastrointestinal surgery under general anesthesia in elderly patients.Participants will collect EEG before and after operation and collect the incidence of postoperative cognitive function to explore the mechanism of postoperative delirium and predict postoperative cognitive dysfunction.

Condition or Disease	Intervention/Treatment	Phase
Perioperative Period Anesthetic Postoperative Cognitive Dysfunction Postoperative Delirium

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

The Second Affiliated Hospital of Nanchang University

Actual Study Start Date :

Apr 13, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
delirium Patients present with delirium within 7 days after general anesthesia
non delirium The patient did not develop delirium for 7 days after general anesthesia

Outcome Measures

Primary Outcome Measures

wave time-frequency analysis [one day before surgery, 7-10 days after surgery]
The characteristics of four kinds of brain wave α, β ,δ and θ were analyzed by professional EEG analysis software
P300 latency and peak changes [one day before surgery, 7-10 days after surgery]
The feature analysis of event-related potentials was carried out through professional EEG analysis software
EEG event-related potential accuracy and response time [one day before surgery, 7-10 days after surgery]
The accuracy of task EEG was analyzed statistically by using professional EEG analysis software
Incidence of postoperative short-term cognitive dysfunction [postoperative 1,3,6 months]
A telephone return visit was conducted on patients using the Revised Cognitive Function Telephone Questionnaire (TICS-M) at 1, 3, and 6 months after discharge.The total score was less than 28 points, which was considered as cognitive impairment.

Secondary Outcome Measures

Systolic pressure [perioperative period]
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Diastolic pressure [perioperative period]
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Mean pressure [perioperative period]
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Heart rate [perioperative period]
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Maximum postoperative C-reactive protein (CRP) [Up to 1 month after surgery]
Only the highest CRP values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed
Minimum postoperative albumin [Up to 1 month after surgery]
Only the lowest albumin values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed
Postoperative pain [1, 3, and 7 days after surgery]
The degree of postoperative pain was assessed using the Numerical Rating Scale (NRS). The pain level increased sequentially from 0-10
Complication [During the perioperative period, up to 1 month after surgery]
All the perioperative complications are recorded
Length of hospitalization [After the patient is discharged from the hospital, average 1 month]
The total number of days the patient spent at the hospital for the current consultation

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Education level in primary school or above;
Age ≥65 years old, gender is not limited;
Good communication ability, language expression ability, mental state and consciousness state;
Preoperative simple mental state scale score ≥27 points;
no history of craniocerebral diseases;
For patients who plan to choose abdominal surgery under general anesthesia, the operation time is expected to be about 2h-4h;
ASA anesthesia grade I ~ III;
No general anesthesia contraindications;
Sign informed consent voluntarily;

Exclusion Criteria:

Relative contraindications of general anesthesia: patients with serious heart and lung function diseases, drug allergy history, etc.
Patients with a history of mental illness or long-term psychiatric drugs (dementia, schizophrenia), chronic analgesic drug use history, alcoholism history and cognitive dysfunction;
any cerebrovascular accident occurred within 3 months, such as stroke, transient ischemic attack (TIA), etc.
Diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular disease, diabetic nephropathy);
Chronic hypoxia and carbon dioxide storage, such as chronic obstructive emphysema;
a long history of alcohol abuse;
Unable to cooperate to complete the test, the patient or family rejected the participant.