Intranasal Dexmedetomidine and Perioperative Myocardial Injury (UDOPIE)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction; Myocardial Injury; Coronary Heart Disease; Dexmedetomidine
• Intervention / Treatment: Drug: Intranasal Dexmedetomidine; Drug: Normal saline

Detailed Description

Coronary heart disease (CHD) remains a major global health burden. Percutaneous coronary intervention (PCI) has become a cornerstone treatment for CHD, effectively reducing mortality. Despite its success, perioperative myocardial injury (PMI) is a frequent complication, occurring in 5-30% of patients, depending on the definition and sensitivity of cardiac biomarkers. PMI ranges from a mild, asymptomatic increase in high-sensitivity cardiac troponin (hs-cTn) to overt myocardial infarction. Even minor elevations in troponin are independently associated with increased 30-day and long-term major adverse cardiovascular events (MACE), as well as higher rates of stent thrombosis and restenosis. The pathophysiology of PMI is multifactorial, including distal embolization, side-branch occlusion, coronary dissection, and, importantly, an imbalance between myocardial oxygen supply and demand during the procedure.

Sedation is commonly used during PCI to relieve anxiety, pain, and stress; however, the choice of sedative and its impact on myocardial outcomes remain controversial. Dexmedetomidine, a highly selective α2-adrenoceptor agonist, provides sedation with minimal respiratory depression and has shown potential cardioprotective effects in preclinical and clinical studies, possibly through reducing sympathetic tone, decreasing myocardial oxygen consumption, and attenuating inflammatory and oxidative stress responses. Intranasal administration offers a non-invasive, convenient route with rapid absorption, making it an attractive option for premedication. Nevertheless, robust evidence from large-scale, multicenter randomized controlled trials is lacking.

This trail is designed to evaluate whether preoperative intranasal dexmedetomidine reduces the incidence of perioperative myocardial injury and myocardial infarction in patients undergoing elective PCI compared with placebo.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min Yan, Doctor; Phone Number: 15888210247; Email: zryanmin@zju.edu.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine Group; 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 received intranasal dexmedetomidine (100 μg, sprayed equally into both nostrils, two sprays per nostril) 15 minutes before surgery in the preoperative preparation area.
Placebo Comparator: Normal saline Group; The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.	Drug: Normal saline; The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the end of surgery to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	From the start of the procedure to the end of the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay	Through patients discharge, an average of 2 days after surgery
Hospitalization costs	Hospitalization costs	Through patients discharge, an average of 2 days after surgery
Intraoperative hypotension	Systolic blood pressure <90 mmHg or >30% decrease from baseline	From intervention to end of surgery
Incidence of intraoperative hypoxemia	Oxygen saturation <90% lasting at least 30 seconds	From intervention to end of surgery
Incidence of unplanned hospital readmission within 30 days after surgery	Unplanned hospital readmission	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.	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.	Baseline, 1 day 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.	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.	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.	30 days after surgery
Acute adverse reactions	drug reaction	From intervention to 6 hours after surgery
Incidence of severe bradycardia	Heart rate <40 beats/min	From intervention to 6 hours after surgery
Dosage of vasoactive agents	Including atropine, norepinephrine and nitroglycerin	From intervention to 6 hours after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Infarction; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: 2026-1148

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No