EEG Characteristics and Postoperative Delirium

Frailty Clinical Trial

Official title:

Correlation Between Intraoperative Electroencephalographic Signatures and Postoperative Delirium in Preoperative Frail Elderly Patients Undergoing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06102967
• Other study ID #: lzh123456
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: The First Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this [type of study: observational study ] is to [compare Energy differences in various bands of intraoperative electroencephalogram in elderly patients with postoperative delirium and non delirium.] in [describe participant population selected 69 patients who underwent laparoscopic radical surgery for colorectal cancer on a selective basis]. The main question[s] it aims to answer are: • [Is there any difference in the spectral range of EEG between POD patients and non POD patients] Participants will [Cognitive.•Postoperative delirium.•Preoperative weakness.]

Description:

The goal of this [type of study: observational study ] is to [compare Correlation between EEG data and postoperative delirium in elderly patients undergoing colorectal cancer radical surgery under preoperative frailty monitoring.] in [describe participant population selected 69 patients who underwent laparoscopic radical surgery for colorectal cancer on a selective basis]. The main question[s] it aims to answer are: • [Is there any difference in the spectral range of EEG between POD patients and non POD patients] Participants will [Sedline EEG monitoring electrodes were placed 1cm above the eyebrows on both sides of the patient and at the temples on both sides, and were continuously monitored from the start of anesthesia in the operating room until the end of the surgery.Pay close attention to the vital signs and wait for the patient to fully recover and the vital signs to basically return to the preoperative level before returning to the ward.•Assessment of cognitive function using the Mini Mental State Scale (MMSE) 1 day before surgery and 7 days after surgery.•Preoperative assessment of frailty using the frailty screening scale.•Assess delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU) 1 day, 2 days, 3 days, and 7 days after surgery.].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 69
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• ASA I-III
• The preoperative Frailty Scale (FRAIL) assessed frailty
• The patient or his/her family is informed about the study and signs an informed consent form

Exclusion Criteria:

• Serious insufficiency of heart, liver, kidney and other functions
• Those with a history of psychiatric or neurological illness, long-term use of psychotropic drug
• History of cerebrovascular disease, brain trauma, or surgery
• The patient was allergic to coupler or unable to place electrodes on the head
• The patient was unable to complete the scale assessment as required.Patients with severe attention to hearing impairment were unable to complete the interview
• The patient was diagnosed with delirium before surgery

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Function Abnormal
• Delirium
• Emergence Delirium
• Frailty
• Postoperative Delirium

Intervention

Behavioral:
• delirium
Evaluation of delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU) 1 day, 2 days, 3 days, and 7 days after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhuo Liu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative delirium	Assessing delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU)	1 day, 2 days, 3 days, and 7 days after surgery
Primary	EEG power of each band	Recording frontal lobe electroencephalogram using a sedline root monitor (Masimo, Crop)	During the procedure
Primary	The number of minutes of suppression assessed by visual analysis of the EEG	The burst suppression time was calculated by EEG visual analysis	Throughout the operation