EEG Characteristics and Postoperative Delirium

NCT06102967 | Completed DMC

• 1 other identifier: lzh123456
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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 \[Cognitive.•Postoperative delirium.•Preoperative weakness.\]

Conditions

Postoperative Delirium; Cognitive Function Abnormal; PSI; Frailty

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Non-delirious group

No postoperative delirium occurred

Delirious group

Postoperative delirium occurs

Behavioral: delirium

Interventions

delirium BEHAVIORAL

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

Delirious group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhuo Liu: lead

Study Sites (1)

The first hospital of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

Location

MeSH Terms

Conditions

Emergence Delirium; Cognition Disorders; Frailty

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Qinshuang Liu, master

  The First hosptial of Qinhuangdao

  STUDY DIRECTOR

• Zhaoheng Li, master

  The First hosptial of Qinhuangdao

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 26, 2023
• Study Start: October 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)