NCT07549282Not yet recruitingPhase 4
Intranasal Dexmedetomidine and Perioperative Myocardial Injury
Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions: A Single-Center, Prospective Randomized Controlled Pilot Study
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 9 Apr 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Coronary artery disease
- NCT number
- NCT07549282
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 140
- From 1 Aug 2026 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of agents that may interfere with the study drug within 1 week before surgery, including α₂ adrenergic receptor agonists (e.g., clonidine), receptor antagonists, and tricyclic antidepressants;
Other illness
- 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;
- 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);
- Cognitive assessment cannot be completed due to language, visual or hearing impairment;
Lab values
- Severe cardiac dysfunction (left ventricular ejection fraction \<40%), New York Heart Association (NYHA) class III-IV heart failure, cardiogenic shock, or hemodynamic instability;
- Hepatic or renal insufficiency (alanine aminotransferase, aspartate aminotransferase, or serum creatinine exceeding 3 times the upper limit of normal reference values);
Other
- Body mass index (BMI) \>30 kg/m²;
- Nasal anatomical abnormalities that preclude intranasal spray administration;
- Pregnant or breastfeeding women;
- Participation in other conflicting clinical trials.
Who the study is looking for
- 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).
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.