Intraoperative Dexmedetomidine Use and Postoperative Delirium After Cardiac Surgery (NCT07759297) | Clinical Trial Compass
CompletedNot Applicable
Intraoperative Dexmedetomidine Use and Postoperative Delirium After Cardiac Surgery
China5,468 participantsStarted 2023-04-01
Plain-language summary
The goal of this observational study is to evaluate whether intraoperative dexmedetomidine use is associated with postoperative delirium in adults undergoing cardiac surgery. The study includes two linked components. First, researchers will analyze routinely collected clinical data from patients who underwent cardiac surgery at Tongji Hospital between January 2015 and December 2025. Second, archived plasma samples from a previously established observational cohort will be tested for matrix metalloproteinase-8 (MMP-8), a blood protein involved in inflammation and tissue injury. Researchers will compare patients who received dexmedetomidine during surgery with patients who did not receive dexmedetomidine. The decision to administer dexmedetomidine was made by the attending anesthesiologist based on the patient's clinical condition and routine anesthetic practice and was not assigned by the study protocol. The study will examine the associations among intraoperative dexmedetomidine use, perioperative changes in MMP-8, and postoperative delirium.
Who can participate
Age range
18 Years – 80 Years
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:
* Adults aged 18 to 80 years.
* Patients who underwent cardiac surgery with cardiopulmonary bypass at Tongji Hospital during the predefined study period.
* Availability of perioperative medication records and postoperative medical and nursing records sufficient to determine intraoperative dexmedetomidine exposure and postoperative delirium status.
* For the biomarker subcohort, availability of archived plasma samples collected preoperatively, at the end of surgery, and 24 hours postoperatively, together with linked clinical data.
Exclusion Criteria:
* Pregnancy.
* Inability to communicate effectively because of severe visual, auditory, or language impairment.
* Preoperative delirium or dementia.
* A history of severe psychiatric illness, including schizophrenia or severe depressive disorder.
* Long-term or high-dose use of antipsychotic medications.
* Intolerance or allergy to benzodiazepines.
* Myasthenia gravis.
* Acute stroke or severe traumatic brain injury within the preceding 6 months.
* Previous solid-organ or bone marrow transplantation.
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
Incidence of Postoperative Delirium
Timeframe: From the end of surgery through postoperative day 7 or hospital discharge, whichever occurred first