EEG Characteristics and Postoperative Delirium

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

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.]

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium; Frailty; Cognitive Function Abnormal; PSI
• Intervention / Treatment: Behavioral: delirium

Detailed 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.].

• Study Type: Observational
• Enrollment (Estimated): 69

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic radical surgery for colorectal cancer on a scheduled basis.Age ≥ 65 years old, regardless of gender; ASA grading I to III; The preoperative frailty scale (FRAIL) was evaluated as frailty; The patient or their family members voluntarily sign an informed consent form.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-delirious group; No postoperative delirium occurred
Delirious group; Postoperative delirium occurs	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	Assessing delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU)	1 day, 2 days, 3 days, and 7 days after surgery
EEG power of each band	Recording frontal lobe electroencephalogram using a sedline root monitor (Masimo, Crop)	During the procedure
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

Collaborators and Investigators

• Sponsor: Zhuo Liu

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 21, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• 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; Frailty; Emergence Delirium
• Other Study ID Numbers: lzh123456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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