An observational study in Perioperative Period, Anesthetic and Postoperative Cognitive Dysfunction, sponsored by Fuzhou Hua. Recruiting at 1 site in China. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Fuzhou Hua · Observational
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.
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This study's planned enrollment of 40 is below the median of 200 across 418 observational studies indexed under Delirium.
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Patients who met the inclusion and exclusion criteria for gastrointestinal surgery admitted to the Second Affiliated Hospital of Nanchang University.
Exclusion Criteria:
Patients present with delirium within 7 days after general anesthesia
The patient did not develop delirium for 7 days after general anesthesia
wave time-frequency analysis
The characteristics of four kinds of brain wave α, β ,δ and θ were analyzed by professional EEG analysis software
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: postoperative 1,3,6 months
Systolic pressure
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Time frame: perioperative period
Diastolic pressure
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Time frame: perioperative period
Mean pressure
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Time frame: perioperative period
Heart rate
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Time frame: perioperative period
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
Time frame: 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
Time frame: Up to 1 month after surgery
Postoperative pain
The degree of postoperative pain was assessed using the Numerical Rating Scale (NRS). The pain level increased sequentially from 0-10
Time frame: 1, 3, and 7 days after surgery
Complication
All the perioperative complications are recorded
Time frame: During the perioperative period, up to 1 month after surgery
Length of hospitalization
The total number of days the patient spent at the hospital for the current consultation
Time frame: After the patient is discharged from the hospital, average 1 month
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