Correlation Between Perioperative EEG Features and Delirium After General Anesthesia

The Second Affiliated Hospital of Nanchang University

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Fuzhou Hua; Phone Number: 15170238929; Email: huafuzhou@126.com
• Study Contact Backup: Name: Xiuqin Rao; Phone Number: 18270739733; Email: raoxiuqin98@163.com

Study Locations

• China
  • NanChang
    • Jiangxi, NanChang, China
      • Recruiting
      • the Second Affiliated Hospital of Nanchang University, Nanchang University
      • Contact: Fuzhou Hua; Phone Number: 15170238929; Email: huafuzhou@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wave time-frequency analysis	The characteristics of four kinds of brain wave α, β ,δ and θ were analyzed by professional EEG analysis software	one day before surgery, 7-10 days after surgery
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Complication	All the perioperative complications are recorded	During the perioperative period, up to 1 month after surgery
Systolic pressure	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".	perioperative period
Diastolic pressure	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".	perioperative period
Mean pressure	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".	perioperative period
Heart rate	"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".	perioperative period
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

Collaborators and Investigators

• Sponsor: Fuzhou Hua
• Investigators: Study Director: Fuzhou Hua, Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Anesthetics; postoperative delirium; Postoperative Cognitive Dysfunction; Perioperative period
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications; Emergence Delirium
• Other Study ID Numbers: 2023-EEG-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No