The goal of this clinical trial is to determine the effect of pre-operative dexmedetomidine on periprocedural myocardial injury in patients having percutaneous coronary intervention (PCI). The specific research hypothesis is that intranasal administration of 100 μg dexmedetomidine (DEX) reduces the incidence of periprocedural myocardial injury within 48 hours after PCI, as compared with normal saline.
Participants will be randomly assigned in a 1:1 ratio to two groups: the dexmedetomidine group and the placebo group.
Aged 45-85 years(inclusive);
Able to confirm understanding of risks, benefits, and treatment alternatives of receiving intranasal dexmedetomidine, and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.
Diagnosed with coronary artery disease with objective evidence of ischemia or silent ischemia, meeting the indications for elective PCI.
Designated American Society of Anesthesiologists (ASA) physical status II-Ⅲ (ranging from mild systemic disease to severe underlying conditions; patients with marked limitation in ordinary physical activity, yet still capable of light daily activities).
Allergy or contraindication to dexmedetomidine, including severe sinus bradycardia (resting heart rate < 50 beats/min), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker implantation;
Patients with severe cardiac insufficiency (left ventricular ejection fraction < 40% or New York Heart Association functional class Ⅲ-IV), cardiogenic shock, or hemodynamic instability;
Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) or hypotension (systolic blood pressure < 90 mmHg);
BMI > 30 kg/m²;
Parallel
Intranasal dexmedetomidine
DrugPatients will receive intranasal DEX (100 μg) 60 ± 10 minutes before the procedure in the preoperative preparation area, with the solution equally sprayed into both nostrils (two sprays per nostril).
Normal Saline
DrugPatients will receive an equal volume of intranasal normal saline containing no active ingredient.
Myocardial injury occurring within 48 hours after surgery
In patients with a normal baseline cardiac troponin (cTn, whether non-high sensitivity cTnT or cTnI) 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
Delirium within the first postoperative day
The 3D-CAM scale will be used to evaluate participants for postoperative delirium.
Acute kidney injury in 48 hours after PCI
An absolute increase in serum creatinine of ≥0.3 mg/dL within 48 hours after PCI, or a relative increase in serum creatinine of ≥50% within 7 days after PCI
A collapsed (one or more) composite of serious cardiovascular complications within 30 days after PCI
Components of the composite are: (1) myocardial infarction; (2) new-onset stroke or transient ischemic attack (TIA); (3) all-cause mortality; (4) any unplanned repeat revascularization; (5) arrhythmias requiring electrical or pharmacological treatment.
Postoperative first-night sleep quality
Sleep quality during the surgical night will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) on the morning of postoperative day 1.This scale consists of 6 dimensions, each scored on a scale of 0 to 100, with higher scores indicating better sleep quality.
Perioperative anxiety score
Peri-operative anxiety status will be assessed with the Perioperative Anxiety Scale-7 (PAS-7). This scale consists of 7 dimensions, each scored on a scale of 0 to 4, with higher scores indicating more severe anxiety symptoms.
Peak postoperative cardiac troponin
Marker values will be standardised (multiples of the upper-reference-limit, ×URL) according to different types of cardiac biomarkers.
Intraoperative pain score
Pain intensity assessed immediately post-procedure by Numeric Rating Scale（NRS）. This scale is scored on a scale of 0 to 10, with higher scores indicating more severe pain.
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