Perioperative PeriodNCT06082024
Correlation Between Perioperative EEG Features and Delirium After General Anesthesia
An observational study of Perioperative Period and Anesthetic, run by Fuzhou Hua at 1 site in China.
Trial summary
The goal of this observational study is to compare the perioperative EEG characteristics and the incidence of short-term cognitive dysfunction in patients with postoperative delirium and non-postoperative delirium after elderly (> 65 years old) patients undergoing major gastrointestinal surgery under general… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Perioperative Period, Anesthetic, Postoperative Cognitive Dysfunction
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2023to Jun 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 80 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who met the inclusion and exclusion criteria for gastrointestinal surgery admitted to the Second Affiliated Hospital of Nanchang University.
Who may be able to join
- Education level in primary school or above;
- Age ≥65 years old, gender is not limited;
- Good communication ability, language expression ability, mental state and consciousness state;
- Preoperative simple mental state scale score ≥27 points;
- no history of craniocerebral diseases;
- For patients who plan to choose abdominal surgery under general anesthesia, the operation time is expected to be about 2h-4h;
Show all 9Show fewer
- ASA anesthesia grade I ~ III;
- No general anesthesia contraindications;
- Sign informed consent voluntarily;
Who cannot join
- Relative contraindications of general anesthesia: patients with serious heart and lung function diseases, drug allergy history, etc.
- Patients with a history of mental illness or long-term psychiatric drugs (dementia, schizophrenia), chronic analgesic drug use history, alcoholism history and cognitive dysfunction;
- any cerebrovascular accident occurred within 3 months, such as stroke, transient ischemic attack (TIA), etc.
- Diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular disease, diabetic nephropathy);
- Chronic hypoxia and carbon dioxide storage, such as chronic obstructive emphysema;
- a long history of alcohol abuse;
- Unable to cooperate to complete the test, the patient or family rejected the participant.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Nanchang University, Nanchang University
Jiangxi, NanChang
Fuzhou Hua, 15170238929, huafuzhou@126.com
About this study
Official title: The Second Affiliated Hospital of Nanchang University
The goal of this observational study is to compare the perioperative EEG characteristics and the incidence of short-term cognitive dysfunction in patients with postoperative delirium and non-postoperative delirium after elderly (> 65 years old) patients undergoing major gastrointestinal surgery under general anesthesia. The main question it aims to answer are: • The correlation between postoperative cognitive dysfunction and postoperative EEG features was evaluated.• To analyze the correlation between EEG characteristics and clinical risk factors of delirium after major abdominal gastrointestinal surgery under general anesthesia in elderly patients.Participants will collect EEG before and after operation and collect the incidence of postoperative cognitive function to explore the mechanism of postoperative delirium and predict postoperative cognitive dysfunction.
- Conditions
- Perioperative Period, Anesthetic, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Keywords
- Perioperative period, Anesthetics, Postoperative Cognitive Dysfunction, postoperative delirium
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| delirium | Patients present with delirium within 7 days after general anesthesia | |
| non delirium | The patient did not develop delirium for 7 days after general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
wave time-frequency analysis
The characteristics of four kinds of brain wave α, β ,δ and θ were analyzed by professional EEG analysis software
Measured: one day before surgery, 7-10 days after surgery
P300 latency and peak changes
The feature analysis of event-related potentials was carried out through professional EEG analysis software
Measured: one day before surgery, 7-10 days after surgery
EEG event-related potential accuracy and response time
The accuracy of task EEG was analyzed statistically by using professional EEG analysis software
Measured: one day before surgery, 7-10 days after surgery
Incidence of postoperative short-term cognitive dysfunction
A telephone return visit was conducted on patients using the Revised Cognitive Function Telephone Questionnaire (TICS-M) at 1, 3, and 6 months after discharge.The total score was less than 28 points, which was considered as cognitive impairment.
Measured: postoperative 1,3,6 months
Secondary outcomes (9)
Systolic pressure
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Measured: perioperative period
Diastolic pressure
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Measured: perioperative period
Mean pressure
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Measured: perioperative period
Heart rate
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Measured: perioperative period
Maximum postoperative C-reactive protein (CRP)
Only the highest CRP values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed
Measured: Up to 1 month after surgery
Minimum postoperative albumin
Only the lowest albumin values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed
Measured: Up to 1 month after surgery
Postoperative pain
The degree of postoperative pain was assessed using the Numerical Rating Scale (NRS). The pain level increased sequentially from 0-10
Measured: 1, 3, and 7 days after surgery
Complication
All the perioperative complications are recorded
Measured: During the perioperative period, up to 1 month after surgery
Length of hospitalization
The total number of days the patient spent at the hospital for the current consultation
Measured: After the patient is discharged from the hospital, average 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start13 Apr 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative PeriodStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou Hua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fuzhou Hua, Second Affiliated Hospital of Nanchang University
- Investigators
- Fuzhou Hua, Study director, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082024
- Sponsor's protocol ID
- 2023-EEG-1
- Status last verified
- Oct 2023
- First submitted
- 5 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital of Nanchang University
- ClinicalTrials.gov ID
- NCT06082024
- Acronym / sponsor ID
- 2023-EEG-1
- Conditions
- Perioperative Period, Anesthetic, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Keywords
- Perioperative period, Anesthetics, Postoperative Cognitive Dysfunction, postoperative delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fuzhou HuaUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 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 observational study is to compare the perioperative EEG characteristics and the incidence of short-term cognitive dysfunction in patients with postoperative delirium and non-postoperative delirium after elderly (> 65 years old) patients undergoing major gastrointestinal surgery under general anesthesia. The main question it aims to answer are: • The correlation between postoperative cognitive dysfunction and postoperative EEG features was evaluated.• To analyze the correlation between EEG characteristics and clinical risk factors of delirium after major abdominal gastrointestinal surgery under general anesthesia in elderly patients.Participants will collect EEG before and after operation and collect the incidence of postoperative cognitive function to explore the mechanism of postoperative delirium and predict postoperative cognitive dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delirium | – | –Patients present with delirium within 7 days after general anesthesia |
| non delirium | – | –The patient did not develop delirium for 7 days after general anesthesia |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who met the inclusion and exclusion criteria for gastrointestinal surgery admitted to the Second Affiliated Hospital of Nanchang University.
Key inclusion criteria (9 listed)
- Education level in primary school or above;
- Age ≥65 years old, gender is not limited;
- Good communication ability, language expression ability, mental state and consciousness state;
- Preoperative simple mental state scale score ≥27 points;
- no history of craniocerebral diseases;
Key exclusion criteria (7 listed)
- Relative contraindications of general anesthesia: patients with serious heart and lung function diseases, drug allergy history, etc.
- Patients with a history of mental illness or long-term psychiatric drugs (dementia, schizophrenia), chronic analgesic drug use history, alcoholism history and cognitive dysfunction;
- any cerebrovascular accident occurred within 3 months, such as stroke, transient ischemic attack (TIA), etc.
- Diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular disease, diabetic nephropathy);
- Chronic hypoxia and carbon dioxide storage, such as chronic obstructive emphysema;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
wave time-frequency analysis
Time frame: one day before surgery, 7-10 days after surgery
The characteristics of four kinds of brain wave α, β ,δ and θ were analyzed by professional EEG analysis software
P300 latency and peak changes
Time frame: one day before surgery, 7-10 days after surgery
The feature analysis of event-related potentials was carried out through professional EEG analysis software
EEG event-related potential accuracy and response time
Time frame: one day before surgery, 7-10 days after surgery
The accuracy of task EEG was analyzed statistically by using professional EEG analysis software
Incidence of postoperative short-term cognitive dysfunction
Time frame: postoperative 1,3,6 months
A telephone return visit was conducted on patients using the Revised Cognitive Function Telephone Questionnaire (TICS-M) at 1, 3, and 6 months after discharge.The total score was less than 28 points, which was considered as cognitive impairment.
9 secondary outcomes
Systolic pressure
Time frame: perioperative period
Diastolic pressure
Time frame: perioperative period
Mean pressure
Time frame: perioperative period
Heart rate
Time frame: perioperative period
Maximum postoperative C-reactive protein (CRP)
Time frame: Up to 1 month after surgery
Minimum postoperative albumin
Time frame: Up to 1 month after surgery
Postoperative pain
Time frame: 1, 3, and 7 days after surgery
Complication
Time frame: During the perioperative period, up to 1 month after surgery
Length of hospitalization
Time frame: After the patient is discharged from the hospital, average 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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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.
Fuzhou Hua study director
Second Affiliated Hospital of Nanchang University
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 Perioperative Period and Anesthetic, run by Fuzhou Hua 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuzhou Hua (15170238929, huafuzhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wave time-frequency analysis (time frame: one day before surgery, 7-10 days after surgery). The study lists 4 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 13 Oct 2023.