Postoperative DeliriumNCT06102967
EEG Characteristics and Postoperative Delirium
An observational study of Postoperative Delirium and Cognitive Function Abnormal, run by Zhuo Liu at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Postoperative Delirium, Cognitive Function Abnormal, PSI
- What is being tested?
- delirium
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Intraoperative Electroencephalographic Signatures and Postoperative Delirium in Preoperative Frail Elderly Patients Undergoing
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.]
Read the 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.].
- Conditions
- Postoperative Delirium, Cognitive Function Abnormal, PSI, Frailty
- Being tested
- delirium
- Medical subject headings
- Emergence Delirium, Cognition Disorders, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deliriumBehavioural
Evaluation of delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU) 1 day, 2 days, 3 days, and 7 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| Non-delirious group | No postoperative delirium occurred | |
| Delirious group | Postoperative delirium occurs Receives: Behavioral: delirium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Assessing delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU)
Measured: 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)
Measured: 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
Measured: Throughout the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuo Liu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zhuo Liu, The First Hospital of Qinhuangdao
- Investigators
- Qinshuang Liu, master, Study director, The First hosptial of QinhuangdaoZhaoheng Li, master, Study chair, The First hosptial of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102967
- Sponsor's protocol ID
- lzh123456
- Status last verified
- Aug 2024
- First submitted
- 9 Oct 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Intraoperative Electroencephalographic Signatures and Postoperative Delirium in Preoperative Frail Elderly Patients Undergoing
- ClinicalTrials.gov ID
- NCT06102967
- Acronym / sponsor ID
- lzh123456
- Conditions
- Postoperative Delirium, Cognitive Function Abnormal, PSI, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Zhuo LiuOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.].
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-delirious group | – | –No postoperative delirium occurred |
| Delirious group | – | Behavioral: deliriumPostoperative delirium occurs |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deliriumEvaluation of delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU) 1 day, 2 days, 3 days, and 7 days after surgery | Behavioural | Delirious group |
Primary outcome
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)
EEG power of each band
Time frame: During the procedure
Recording frontal lobe electroencephalogram using a sedline root monitor (Masimo, Crop)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qinshuang Liu, master study director
The First hosptial of Qinhuangdao
Zhaoheng Li, master study chair
The First hosptial of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Cognitive Function Abnormal, run by Zhuo Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: 1 day, 2 days, 3 days, and 7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.