An interventional study of Intranasal dexmedetomidine and Normal Saline in Coronary Heart Disease and Coronary Artery Disease, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Patients 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).
Drug: Intranasal dexmedetomidine
Patients will receive an equal volume of intranasal normal saline containing no active ingredient 60 ± 10 minutes before the procedure.
Drug: Normal Saline
Patients 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).
Patients 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
Time frame: Within 48 hours after surgery
Delirium within the first postoperative day
The 3D-CAM scale will be used to evaluate participants for postoperative delirium.
Time frame: Within the first postoperative day
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
Time frame: Within 48 hours 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.
Time frame: Within 30 days after PCI
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.
Time frame: Postoperative day 1.
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.
Time frame: From study drug administration to 6 hours after PCI.
Peak postoperative cardiac troponin
Marker values will be standardised (multiples of the upper-reference-limit, ×URL) according to different types of cardiac biomarkers.
Time frame: Within 48 hours after PCI
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.
Time frame: Immediately post-procedure.
The EuroQol Five-Dimensional Questionnaire (EQ-5D) scores at 30 days after PCI
Assessed by the EuroQol Five-Dimensional Questionnaire (EQ-5D) at 30 days post-PCI. The EQ-5D comprises 5 dimensions and a visual analogue scale. Each dimension is rated at 5 levels. The EuroQol visual analogue scale (EQ-VAS) requires patients to rate their current overall health on a 0-100 visual analogue scale, where 0 represents the worst health state imaginable and 100 represents the best health state imaginable.
Time frame: At 30 days post-PCI.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) scores at 30 days after PCI
The KCCQ comprises 23 items across 7 domains, each scored on a scale of 0 to 100, with higher scores indicating better health status.
Time frame: At 30 days post-PCI.
Acute adverse reactions
Acute adverse reactions include allergy, dizziness, nausea, vomiting, and other related manifestations.
Time frame: Within the period from drug administration to 6 hours after surgery
Hypotension
A mean arterial pressure (MAP) below 65 mmHg or a reduction of more than 30% from baseline.
Time frame: Within the period from drug administration to 6 hours after surgery.
Severe bradycardia
A heart rate below 40 beats per minute.
Time frame: Within the period from drug administration to 6 hours after surgery.
Hypoxemia
An oxygen saturation below 90% lasting for at least 30 seconds.
Time frame: Within the period from drug administration to 6 hours after surgery.
Dosage of vasoactive agents
Vasoactive agents includes atropine, norepinephrine, and nitroglycerin.
Time frame: Within the period from drug administration to 6 hours after surgery.
Local nasal adverse reactions
Local nasal adverse reactions: including nasal discomfort, irritation, nasal congestion, rhinorrhoea, epistaxis, dysgeusia, and incomplete delivery of study nasal-spray medication.
Time frame: Within the period from drug administration to 6 hours after surgery.
Plan to share: No
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Second Affiliated Hospital, Zhejiang University, School of Medicine