Correlation Between Perioperative EEG Features and Delirium After General Anesthesia

Recruiting

• Conditions: Perioperative Period; Anesthetic; Postoperative Delirium; Postoperative Cognitive Dysfunction

• Registration Number: NCT06082024
• Lead Sponsor: Fuzhou Hua

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-13
• Study First Submitted: 2023-09-05
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-08
• Last Update Submitted: 2023-10-08
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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.
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
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

Secondary Outcome Measures

Name	Time	Method
Mean pressure	perioperative period	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
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
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
Diastolic pressure	perioperative period	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
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
Systolic 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".
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

Trial Locations

Locations (1)

the Second Affiliated Hospital of Nanchang University, Nanchang University; 🇨🇳 Jiangxi, NanChang, China