A Phase 4 interventional study of Intranasal Dexmedetomidine and Normal saline in Coronary Heart Disease, Myocardial Injury and Myocardial Infarction, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 4, Interventional, and Prevention
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.
Exclusion Criteria:
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: Intranasal Dexmedetomidine
The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.
Drug: Normal saline
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.
The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.
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
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.
Time frame: From the start of the procedure to the end of the procedure
Incidence of unplanned hospital readmission within 30 days after surgery
Unplanned hospital readmission
Time frame: 30 days after surgery
Change in perioperative anxiety scores
Anxiety was also assessed using the Perioperative Anxiety Scale-7 (PAS-7) , which ranges from 0 to 28, with higher scores indicating greater anxiety.
Time frame: Before intervention; after intervention but before surgery; 1 day after surgery
Sleep quality scores on postoperative day 1
Sleep quality was assessed using the Richards Campbell Sleep Questionnaire (RCSQ), RCSQ uses a visual analog scale ranging from 0 to 100 for each item, where 0 represents the worst possible sleep condition (or the most negative description) and 100 represents the best possible sleep condition (or the most positive description). Patients are asked to place a slider at the position that best describes their sleep status the previous night. The total RCSQ sleep score is calculated as the mean of the first five items (Items 6-10). The sixth item (Item 11) assesses noise level and is scored separately.
Time frame: Baseline, 1 day after surgery
Hospitalization costs
Hospitalization costs
Time frame: Through patients discharge, an average of 2 days after surgery
Postoperative pain scores
Pain was assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating more severe pain.
Time frame: Immediately after surgery
Quality of life scores at 30 days after surgery
Quality of life was assessed using the EuroQol Five-Dimensional Questionnaire (EQ-5D) EuroQol Five-Dimensional Questionnaire (EQ-5D): The EQ-5D includes a visual analog scale (EQ-VAS) ranging from 0 to 100, where higher scores indicate better health status.
Time frame: 30 days after surgery
Quality of life scores at 30 days after surgery
Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Kansas City Cardiomyopathy Questionnaire (KCCQ): The KCCQ consists of 23 items that quantify the following domains: physical limitations, symptoms (including symptom frequency, severity, and change over time), self-efficacy, social function, and quality of life. The total score ranges from 0 to 100, with higher scores representing better quality of life.
Time frame: 30 days after surgery
Length of hospital stay
Length of hospital stay
Time frame: Through patients discharge, an average of 2 days after surgery
Acute adverse reactions
drug reaction
Time frame: From intervention to 6 hours after surgery
Intraoperative hypotension
Systolic blood pressure \<90 mmHg or \>30% decrease from baseline
Time frame: From intervention to end of surgery
Incidence of intraoperative hypoxemia
Oxygen saturation \<90% lasting at least 30 seconds
Time frame: From intervention to end of surgery
Incidence of severe bradycardia
Heart rate \<40 beats/min
Time frame: From intervention to 6 hours after surgery
Dosage of vasoactive agents
Including atropine, norepinephrine and nitroglycerin
Time frame: From intervention to 6 hours after surgery
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University