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Набор скоро начнётся NCT07549282

Intranasal Dexmedetomidine and Perioperative Myocardial Injury

Фаза IV С лечением Coronary Heart Disease Myocardial Injury Myocardial Infarction Dexmedetomidine

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intranasal Dexmedetomidine, Normal saline.
Кому может быть актуально
Состояния в реестре: Coronary Heart Disease, Myocardial Injury, Myocardial Infarction, Dexmedetomidine. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат 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.
  • Препарат Normal saline
    The subjects were given an equal volume of normal saline intranasally, which contained no active ingredient.

Первичные конечные точки

  • Incidence of perioperative myocardial injury [Срок оценки: From the end of surgery to 48 hours after surgery]
Вторичные конечные точки (4)
  • Incidence of major perioperative myocardial injury [Срок оценки: From the end of surgery to 48 hours after surgery]
  • Composite outcome at 30 days after PCI [Срок оценки: 30 days after surgery]
  • Blood pressure stability [Срок оценки: From the start of the procedure to the end of the procedure]
  • Perioperative myocardial oxygen consumption [Срок оценки: From the start of the procedure to the end of the procedure]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Ханчжоу

Идентификаторы

NCT: NCT07549282 · 2026-1148

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗