Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Hear… (NCT05001425) | Clinical Trial Compass
UnknownNot Applicable
Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass
China90 participantsStarted 2020-07-01
Plain-language summary
The purpose of this study is to explorethe brain excitability in patients undergoing heart valve replacement surgery with cardiopulmonary bypass and the correlation with postoperative delirium
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ASA Ⅱ - Ⅲ;
. No cognitive impairment was assessed one day before surgery;
. Patients undergoing elective heart valve replacement under CPB and signed informed consent.
. Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;
. Inability to communicate with language impairment or major hearing or visual impairment;
. Liver function child-pugh Grade C, severe liver dysfunction;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of delirium after cardiac surgery
Timeframe: The first day after surgery
2
The incidence of delirium after cardiac surgery
Timeframe: The second day after surgery
3
The incidence of delirium after cardiac surgery
Timeframe: The third day after surgery
4
Abnormal EEG during surgery
Timeframe: Complete EEG information from entry to exit of the operating room
5
Plasma excitatory amino acid levels
Timeframe: Before the operation after entering the operating room (baseline)
6
Plasma excitatory amino acid levels
Timeframe: Immediately after surgery
7
Plasma excitatory amino acid levels
Timeframe: 24 hours after surgery
Trial details
NCT IDNCT05001425
SponsorGeneral Hospital of Ningxia Medical University