Use Dexmedetomidine To Protect Myocardial Injury Evaluation (UDOPIE)

Effects of Preoperative Intranasal Dexmedetomidine on Perioperative Myocardial Injury and Myocardial Infarction in Patients Undergoing Percutaneous Coronary Intervention: A Prospective, Randomized Controlled Trial

The goal of this clinical trial is to learn if preoperative intranasal dexmedetomidine works to reduce perioperative myocardial injury and myocardial infarction in patients undergoing elective percutaneous coronary intervention (PCI). It will also learn about the safety of intranasal dexmedetomidine. The main questions it aims to answer are:

Does preoperative intranasal dexmedetomidine lower the incidence of perioperative myocardial injury and myocardial infarction after PCI? Does intranasal dexmedetomidine cause safety concerns in patients undergoing PCI? Researchers will compare intranasal dexmedetomidine to a placebo (a look-alike substance that contains no drug) to see if intranasal dexmedetomidine works to protect the heart during PCI.

Participants will:

Receive either intranasal dexmedetomidine (100 μg) or a placebo (normal saline) 15 minutes before the PCI procedure Undergo blood tests to measure cardiac troponin levels before and after the procedure Be followed for up to 30 days after the procedure to record any heart-related events or side effects

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): 1800
• 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:

• 18 years ≤ age ≤ 85 years;
• Patients scheduled to undergo elective coronary angiography or percutaneous coronary intervention (PCI);
• Classified as American Society of Anesthesiologists (ASA) physical status I-III (ranging from patients with mild systemic disease to those with more severe systemic disease that limits normal physical activity but who remain able to perform light daily tasks);
• Informed consent obtained.

Exclusion Criteria:

• Allergy or contraindication to dexmedetomidine, such as severe bradycardia (resting heart rate <50 beats/min), sick sinus syndrome, second-degree or higher atrioventricular block without a pacemaker;
• Severe cardiac dysfunction (left ventricular ejection fraction <35% or New York Heart Association functional class III-IV), cardiogenic shock, or hemodynamically unstable patients;
• Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) or hypotension (systolic blood pressure <90 mmHg);
• Sleep apnea-hypopnea syndrome or Body Mass Index >30 kg/m²;
• Use of alpha-2 adrenergic receptor agonists (e.g., clonidine) or antagonists, or tricyclic antidepressants, which may affect the action of the study drug, within 1 month before the procedure;
• Language, visual, or hearing impairment that may affect cognitive assessment;
• Hepatic or renal insufficiency (Alanine Aminotransferase/Aspartate Aminotransferase/Creatinine >3 times the upper limit of normal);
• Anatomical abnormalities of the nasal cavity affecting intranasal drug administration;
• Pregnant or breastfeeding women.

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
Composite incidence of perioperative myocardial injury and myocardial infarction	Perioperative Myocardial Injury and Perioperative Myocardial Infarction: As defined by the Fourth Universal Definition of Myocardial Infarction	from the end of surgery to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of perioperative myocardial injury	Perioperative Myocardial Injury	from the end of surgery to 48 hours after surgery
Incidence of perioperative myocardial infarction	Perioperative Myocardial infarction	from the end of surgery to 48 hours after surgery
Incidence of severe perioperative myocardial injury	severe 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
Incidence of major adverse cardiac and cerebrovascular events (MACCE) within 4 and 12 weeks after surgery	Myocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death	4 and 12 weeks after surgery
Incidence of unplanned hospital readmission within 4 and 12 weeks after surgery	Unplanned hospital readmission	4 and 12 weeks after surgery
Variability of mean arterial pressure and systolic blood pressure	Hemodynamic variable	From operating room admission to 24 hours postoperatively
Change in perioperative anxiety scores	Anxiety was assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating greater anxiety. 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
Change in perioperative cardiac enzyme levels	Myocardial enzyme level	Baseline, 6 hours after surgery, 24 hours after surgery or before discharge
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 and one first day after surgery
Sleep quality scores on postoperative day 1 and day 2	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, 2day after surgery
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
Quality of life scores at 4 and 12 weeks 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.	Baseline, 4 and 12 weeks after surgery
Quality of life scores at 4 and 12 weeks 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.	Baseline, 4 and 12 weeks after surgery
Acute adverse reactions	drug reaction	from intervention to 6 hours 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 severe bradycardia	Heart rate <50 beats/min	From intervention to 6 hours after surgery
Utilization rate of vasoactive drugs	atropine, ephedrine/norepinephrine	From intervention to 6 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of MACCE at 1 year after surgery	Myocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death	1 year after surgery
Quality of life scores at 1 year 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.	1 year after surgery
Quality of life scores at 1 year 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.	1 year after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028

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): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: March 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: 2026-0521

Drug and device information, study documents

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