Intranasal Dexmedetomidine and Perioperative Myocardial Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intranasal Dexmedetomidine, Normal saline.
- Who it may be relevant to
- Registry conditions: Coronary Heart Disease, Myocardial Injury, Myocardial Infarction, Dexmedetomidine. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions: A Single-Center, Prospective Randomized Controlled Pilot Study
Overview
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.
Interventions
- Drug Intranasal Dexmedetomidine
The subjects received intranasal dexmedetomidine (100 μg, sprayed equally into both nostrils, two sprays per nostril) 15 minutes before surgery in the preoperative preparation area. - Drug Normal saline
The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.
Primary outcome measures
- Incidence of perioperative myocardial injury [Time frame: From the end of surgery to 48 hours after surgery]
Secondary outcome measures (4)
- Incidence of major perioperative myocardial injury [Time frame: From the end of surgery to 48 hours after surgery]
- Composite outcome at 30 days after PCI [Time frame: 30 days after surgery]
- Blood pressure stability [Time frame: From the start of the procedure to the end of the procedure]
- Perioperative myocardial oxygen consumption [Time frame: From the start of the procedure to the end of the procedure]
Eligibility criteria
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 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;
- Cognitive assessment cannot be completed due to language, visual or hearing impairment;
- Hepatic or renal insufficiency (alanine aminotransferase, aspartate aminotransferase, or serum creatinine exceeding 3 times the upper limit of normal reference values);
- Nasal anatomical abnormalities that preclude intranasal spray administration;
- Pregnant or breastfeeding women;
- Participation in other conflicting clinical trials.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou
Identifiers
NCT: NCT07549282 · 2026-1148