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Clinical Trials/NCT06102967
NCT06102967
Completed
Not Applicable

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

Zhuo Liu1 site in 1 country66 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
Zhuo Liu
Enrollment
66
Locations
1
Primary Endpoint
The number of minutes of suppression assessed by visual analysis of the EEG
Status
Completed
Last Updated
last year

Overview

Brief 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.]

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 \[Sedline EEG monitoring electrodes were placed 1cm above the eyebrows on both sides of the patient and at the temples on both sides, and were continuously monitored from the start of anesthesia in the operating room until the end of the surgery.Pay close attention to the vital signs and wait for the patient to fully recover and the vital signs to basically return to the preoperative level before returning to the ward.•Assessment of cognitive function using the Mini Mental State Scale (MMSE) 1 day before surgery and 7 days after surgery.•Preoperative assessment of frailty using the frailty screening scale.•Assess delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU) 1 day, 2 days, 3 days, and 7 days after surgery.\].

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
July 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Zhuo Liu
Responsible Party
Sponsor Investigator
Principal Investigator

Zhuo Liu

Principal Investigator

The First Hospital of Qinhuangdao

Eligibility Criteria

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

Outcomes

Primary Outcomes

The number of minutes of suppression assessed by visual analysis of the EEG

Time Frame: Throughout the operation

The burst suppression time was calculated by EEG visual analysis

EEG power of each band

Time Frame: During the procedure

Recording frontal lobe electroencephalogram using a sedline root monitor (Masimo, Crop)

Postoperative delirium

Time Frame: 1 day, 2 days, 3 days, and 7 days after surgery

Assessing delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU)

Study Sites (1)

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