Intranasal Dexmedetomidine and Perioperative Myocardial Injury
China140 participantsStarted 2026-08
Plain-language summary
PCI is the standard treatment for CAD, yet perioperative myocardial injury occurs frequently in nearly 40% of patients. Perioperative stress and sympathetic overactivation break myocardial oxygen balance and lead to cardiac damage, which further raises short-term cardiovascular events and long-term mortality risks. Dexmedetomidine exerts cardioprotective effects by inhibiting sympathetic excitation, though intravenous use carries risks of hypotension and bradycardia. Intranasal dexmedetomidine shows equivalent efficacy with fewer side effects and better patient compliance. Since no standard perioperative anesthesia regimen exists for elective PCI patients and the clinical benefits of dexmedetomidine remain unconfirmed, this pilot study is designed to test the feasibility and safety of intranasal dexmedetomidine spray before launching large formal RCTs.
Who can participate
Age range
18 Years – 85 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:
* Aged between 18 and 85 years old;
* Subjects are fully informed of the risks, benefits and alternative treatment regimens of intranasal dexmedetomidine administration. Written informed consent is signed by the subject themselves or their legal representative prior to any study-related procedures;
* Confirmed diagnosis of coronary artery disease with objective evidence of myocardial ischemia or silent myocardial ischemia, and indications for elective percutaneous coronary intervention (PCI);
* American Society of Anesthesiologists (ASA) physical status classification II to III (patients with mild to severe systemic underlying diseases; ordinary physical activities are markedly limited, yet mild daily activities can be performed).
Exclusion Criteria:
* Subjects with hypersensitivity or contraindications to dexmedetomidine, including severe sinus bradycardia (resting heart rate \<50 beats per minute), sick sinus syndrome, and second-degree or higher atrioventricular block without pacemaker implantation;
* Severe cardiac dysfunction (left ventricular ejection fraction \<40%), New York Heart Association (NYHA) class III-IV heart failure, cardiogenic shock, or hemodynamic instability;
* Poorly controlled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg), or hypotension (systolic blood pressure \<90 mmHg);
* Coexisting obstructive sleep apnea hypopnea syndrome (OSAHS);
* Body mass index (BMI) \>30 kg/m²;
* Use of agents…
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.
1This trial is testing whether dexmedetomidine can reduce heart muscle injury during surgery in people with coronary heart disease — given that it's a Phase 4 study, what does that mean for how much is already known about dexmedetomidine's safety compared to earlier-phase trials?
2The trial is listed as 'not yet recruiting,' so if this might be a good fit for me, how soon do you expect it to open, and should I be doing anything now to prepare or stay on a standard treatment path in the meantime?
3The trial is measuring a 'composite' outcome of both perioperative myocardial injury and myocardial infarction — can you explain what that means for me specifically, and how my own risk of those events during surgery would factor into whether a trial like this makes sense?
4Are there standard-of-care options already available to protect my heart during surgery that I should consider first, or would participating in this trial be compatible with those approaches?
5What would my involvement in this trial actually look like day-to-day — for example, how would dexmedetomidine be given, how long would I need to be monitored, and how does that fit with my overall surgical and recovery plan?
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 perioperative myocardial injury
Timeframe: From the end of surgery to 48 hours after surgery
Trial details
NCT IDNCT07549282
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine