Correlation Between Perioperative EEG Features and Delirium After General Anesthesia

NCT06082024 | Unknown

• 1 other identifier: 2023-EEG-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Period; Anesthetic; Postoperative Cognitive Dysfunction; Postoperative Delirium

Keywords

Perioperative period; Anesthetics; Postoperative Cognitive Dysfunction; postoperative delirium

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Systolic pressure

  perioperative period

• Diastolic pressure

  perioperative period

• Mean pressure

  perioperative period

• Heart rate

  perioperative period

• Maximum postoperative C-reactive protein (CRP)

  Up to 1 month after surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuzhou Hua: lead

Study Sites (1)

the Second Affiliated Hospital of Nanchang University, Nanchang University

Jiangxi, NanChang, China

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Fuzhou Hua

  Second Affiliated Hospital of Nanchang University

  STUDY DIRECTOR

Central Study Contacts

Fuzhou Hua

CONTACT

15170238929; huafuzhou@126.com

Xiuqin Rao

CONTACT

18270739733; raoxiuqin98@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: October 13, 2023
• Study Start: April 13, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

CN (1)