Correlation Between Perioperative EEG Features and Delirium After General Anesthesia

Postoperative Delirium Clinical Trial

Official title:

The Second Affiliated Hospital of Nanchang University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082024
• Other study ID #: 2023-EEG-1
• Status: Recruiting
• Start date: April 13, 2023
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital of Nanchang University
• Contact: Fuzhou Hua
• Phone: 15170238929
• Email: huafuzhou[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthetic
• Cognitive Dysfunction
• Delirium
• Emergence Delirium
• Perioperative Period
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Postoperative Delirium

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Nanchang University, Nanchang University	Jiangxi	NanChang

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou Hua

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wave time-frequency analysis	The characteristics of four kinds of brain wave a, ß ,d and ? were analyzed by professional EEG analysis software	one day before surgery, 7-10 days after surgery
Primary	P300 latency and peak changes	The feature analysis of event-related potentials was carried out through professional EEG analysis software	one day before surgery, 7-10 days after surgery
Primary	EEG event-related potential accuracy and response time	The accuracy of task EEG was analyzed statistically by using professional EEG analysis software	one day before surgery, 7-10 days after surgery
Primary	Incidence of postoperative short-term cognitive dysfunction	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.	postoperative 1,3,6 months
Secondary	Systolic pressure	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".	perioperative period
Secondary	Diastolic pressure	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".	perioperative period
Secondary	Mean pressure	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".	perioperative period
Secondary	Heart rate	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".	perioperative period
Secondary	Maximum postoperative C-reactive protein (CRP)	Only the highest CRP values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed	Up to 1 month after surgery
Secondary	Minimum postoperative albumin	Only the lowest albumin values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed	Up to 1 month after surgery
Secondary	Postoperative pain	The degree of postoperative pain was assessed using the Numerical Rating Scale (NRS). The pain level increased sequentially from 0-10	1, 3, and 7 days after surgery
Secondary	Complication	All the perioperative complications are recorded	During the perioperative period, up to 1 month after surgery
Secondary	Length of hospitalization	The total number of days the patient spent at the hospital for the current consultation	After the patient is discharged from the hospital, average 1 month