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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06102967
Other study ID # lzh123456
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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