Clinical trial NCT06082024: Correlation Between Perioperative EEG Features and Delirium After General Anesthesia
Official title: The Second Affiliated Hospital of Nanchang University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perioperative Period
Anesthetic
Postoperative Cognitive Dysfunction
Postoperative Delirium
Keywords: Perioperative period
Anesthetics
Postoperative Cognitive Dysfunction
postoperative delirium
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who met the inclusion and exclusion criteria for gastrointestinal surgery admitted to the Second Affiliated Hospital of Nanchang University.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: wave time-frequency analysis
timeFrame: one day before surgery, 7-10 days after surgery
measure: P300 latency and peak changes
timeFrame: one day before surgery, 7-10 days after surgery
measure: EEG event-related potential accuracy and response time
timeFrame: one day before surgery, 7-10 days after surgery
measure: Incidence of postoperative short-term cognitive dysfunction
timeFrame: postoperative 1,3,6 months
Secondary outcomes:
measure: Systolic pressure
timeFrame: perioperative period
measure: Diastolic pressure
timeFrame: perioperative period
measure: Mean pressure
timeFrame: perioperative period
measure: Heart rate
timeFrame: perioperative period
measure: Maximum postoperative C-reactive protein (CRP)
timeFrame: Up to 1 month after surgery
measure: Minimum postoperative albumin
timeFrame: Up to 1 month after surgery
measure: Postoperative pain
timeFrame: 1, 3, and 7 days after surgery
measure: Complication
timeFrame: During the perioperative period, up to 1 month after surgery
measure: Length of hospitalization
timeFrame: After the patient is discharged from the hospital, average 1 month
Other outcomes:
Locations:
city: Jiangxi
country: China
facility: the Second Affiliated Hospital of Nanchang University, Nanchang University
state: NanChang
Study officials:
affiliation: Second Affiliated Hospital of Nanchang University
name: Fuzhou Hua
role: STUDY_DIRECTOR
References: