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NCT07549282

PHASE4

Intranasal Dexmedetomidine and Perioperative Myocardial Injury

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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.

Official title: Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions: A Single-Center, Prospective Randomized Controlled Pilot Study

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-08

Completion Date

2027-02

Last Updated

2026-07-30

Healthy Volunteers

Conditions

Coronary Heart Disease Myocardial Injury Myocardial Infarction Dexmedetomidine

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.

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.

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China