Intranasal Dexmedetomidine and Perioperative Myocardial Injury

Phase 4Not Yet RecruitingNCT07549282

Second Affiliated Hospital, Zhejiang University, School of Medicine140 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

140

Conditions

Coronary Heart Disease Myocardial Injury Myocardial Infarction

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of perioperative myocardial injury

Definition of myocardial injury: In patients with a normal baseline cTn concentration (≤99th percentile upper reference limit \[URL\]), postoperative cTn elevation exceeding the 99th percentile URL; In patients with an elevated baseline cTn concentration (\>99th percentile URL) that was stable or decreasing, a postoperative cTn increase of \>20% from baseline, with an absolute value exceeding the 99th percentile URL.

Time frame: From the end of surgery to 48 hours after surgery

Secondary Outcomes

Incidence of major perioperative myocardial injury

For patients with normal baseline cTn levels, a cTn elevation exceeding 5 times the 99th percentile upper reference limit (URL) within 48 hours after PCI .For patients with elevated baseline cTn levels, the post-procedural cTn value must increase by \>20% from baseline, and the absolute post-procedural cTn value must exceed 5 times the 99th percentile upper reference limit (URL).

Time frame: From the end of surgery to 48 hours after surgery

Composite outcome at 30 days after PCI

Consisting of: (1) myocardial infarction; (2) new-onset stroke or transient ischemic attack (TIA); (3) all-cause death; and (4) any unplanned revascularization.

Time frame: 30 days after surgery

Blood pressure stability

Quantified by the absolute real variability of perioperative generalized mean arterial pressure (ARV-MAP). Calculation procedures are as follows: ① For continuous arterial blood pressure waveform data, calculate the mean MAP for each non-overlapping 15-minute time window. ② Compute the absolute value of the difference between the mean MAP of every pair of adjacent time windows. ③ Sum all these absolute values, then divide the total sum by the total observation duration (operative time). A lower ARV-MAP value indicates smaller temporal fluctuations in MAP, meaning more stable blood pressure.

Time frame: From the start of the procedure to the end of the procedure

Perioperative myocardial oxygen consumption

Rate-pressure product (RPP) = heart rate (beats per minute) × systolic blood pressure (mmHg). Blood pressure and heart rate are recorded every 15 minutes after patients enter the operating room, and the mean value of RPP is calculated.