Use Dexmedetomidine To Protect Myocardial Injury Evaluation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this 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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Intranasal Dexmedetomidine
- Normal saline
Treatment groups
1,800 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov