EEG Characteristics and Postoperative Delirium

Sponsor
Zhuo Liu (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06102967
Collaborator
(none)
69
7

Study Details

Study Description

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.]

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
69 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Correlation Between Intraoperative Electroencephalographic Signatures and Postoperative Delirium in Preoperative Frail Elderly Patients Undergoing
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Postoperative delirium [1 day, 2 days, 3 days, and 7 days after surgery]

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

  2. EEG power of each band [During the procedure]

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

  3. The number of minutes of suppression assessed by visual analysis of the EEG [Throughout the operation]

    The burst suppression time was calculated by EEG visual analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zhuo Liu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhuo Liu, Principal Investigator, The First Hospital of Qinhuangdao
ClinicalTrials.gov Identifier:
NCT06102967
Other Study ID Numbers:
  • lzh123456
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2023