Intranasal Dexmedetomidine and Perioperative Myocardial Injury in Patients Having Percutaneous Coronary Interventions: A Prospective, Multi-Center Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Myocardial injury occurring within 48 hours after surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 45-85 years(inclusive);
- •Able to confirm understanding of risks, benefits, and treatment alternatives of receiving intranasal dexmedetomidine, and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.
- •Diagnosed with coronary artery disease with objective evidence of ischemia or silent ischemia, meeting the indications for elective PCI.
- •Designated American Society of Anesthesiologists (ASA) physical status II-Ⅲ (ranging from mild systemic disease to severe underlying conditions; patients with marked limitation in ordinary physical activity, yet still capable of light daily activities).
排除标准
- •Allergy or contraindication to dexmedetomidine, including severe sinus bradycardia (resting heart rate < 50 beats/min), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker implantation;
- •Patients with severe cardiac insufficiency (left ventricular ejection fraction < 40% or New York Heart Association functional class Ⅲ-IV), cardiogenic shock, or hemodynamic instability;
- •Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) or hypotension (systolic blood pressure < 90 mmHg);
- •BMI > 30 kg/m²;
- •Known or suspected sleep apnea;
- •Use of drugs that may interfere with the study medication within 1 week before surgery, including α2-adrenergic receptor agonists (e.g., clonidine) or antagonists, and tricyclic antidepressants;
- •Language, visual, or hearing impairment that may affect questionnaire assessment;
- •Hepatic or renal insufficiency (Alanine Aminotransferase/Aspartate Aminotransferase/Creatinine > 3 times the upper limit of normal);
- •Nasal anatomical abnormalities interfering with nasal spray administration;
- •Pregnant or lactating women;
- •Participation in another clinical trial that may conflict with this trial.
研究组 & 干预措施
Placebo group
Patients will receive an equal volume of intranasal normal saline containing no active ingredient 60 ± 10 minutes before the procedure.
干预措施: Normal Saline (Drug)
Intranasal DEX group
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).
干预措施: Intranasal dexmedetomidine (Drug)
结局指标
主要结局
Myocardial injury occurring within 48 hours after surgery
时间窗: 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
次要结局
- Delirium within the first postoperative day(Within the first postoperative day)
- Acute kidney injury in 48 hours after PCI(Within 48 hours after PCI.)
- A collapsed (one or more) composite of serious cardiovascular complications within 30 days after PCI(Within 30 days after PCI)