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NCT Number: NCT06102967

EEG Characteristics and Postoperative Delirium

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.]

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Key information

Conditions

Postoperative Delirium Cognition Disorders Cognitive Function Abnormal Confusion Delirium Emergence Delirium Frailty Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations PSI Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The first hospital of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

About this study

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.].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

  2. EEG power of each band

    Time frame: 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

    Time frame: Throughout the operation

    The burst suppression time was calculated by EEG visual analysis

Sponsors and collaborators

Lead sponsor

Zhuo Liu

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2023
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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