Intranasal Dexmedetomidine and Perioperative Myocardial Injury
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Intranasal Dexmedetomidine
- Normal saline
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov