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Идёт набор NCT07241572

Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-Knee Lower Extremity Surgery

— Наблюдательное Myocardial Ischemia Diabetes Complication

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: high sensitive Troponin I.
Кому может быть актуально
Состояния в реестре: Myocardial Ischemia, Diabetes Complication. Базовые параметры: от 18 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
Turkey (Türkiye)
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

Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-knee Lower Extremity Surgery With Peripheral Nerve Block

Обзор

The aim of this observational study was to detect myocardial damage by monitoring high-sensitive troponin I levels in patients undergoing below-knee extremity surgery with peripheral nerve block. The primary question it aims to answer is: How effective are peroperative high-sensitive troponin I levels in predicting myocardial damage? High-sensitive troponin I levels will be monitored intraoperatively and at 24 and 48 hours postoperatively.

Подробное описание

Peripheral nerve blocks are becoming increasingly popular in foot and ankle surgery. Patients undergoing peripheral nerve blocks have advantages such as shorter hospital stays, better postoperative pain relief, lower costs, and less opioid use.

A review of current literature revealed that myocardial damage has not been investigated in patients scheduled for below-knee lower extremity surgery. Therefore, we aimed to detect myocardial damage by monitoring high-sensitive troponin I levels, which is considered the most sensitive and effective test according to AHA/ACC (American College of Cardiology and American Heart Association) guidelines at our hospital. The secondary aim of the study was to determine which parameters correlate with myocardial damage.

Preoperatively, the patient's hemogram, biochemistry, and hsTroponin I measurements, all of which were requested during the preparation phase, will be recorded.

During the operation, the type of anesthesia, the amount of local anesthetic and adjuvant medication used for peripheral nerve blockade will be recorded.

Intraoperatively, routine anesthetic monitoring (SpO2, blood pressure, ECG, heart rate), intraoperative presence and duration of hypotension, need for inotropic support, total dose (if any), presence and duration of tachycardia and bradycardia, fluid volume administered, urine output, and operation time will be recorded.

Postoperatively, all patients will be monitored in their ward or intensive care unit. Routine hemogram, biochemistry, and hsTroponin I measurements will be repeated at 24 and 48 hours, and the results will be noted. Postoperative complications will be recorded.

Patients will be followed up for 30 days through the hospital registry and telemedicine at the investigator's discretion, and will be questioned about potential major cardiac events (MACE).

Вмешательства

  • Диагностический тест high sensitive Troponin I
    High sensitive Troponin I used to predict myocardial damage

Первичные конечные точки

  • High sensitive Troponin I [Срок оценки: 01.09.2025-10.01.2026]
  • High sensitive Troponin I [Срок оценки: 01.09.2025-11.01.2026]
  • High sensitive Troponin I [Срок оценки: 01.09.2025-12.01.2026]
Вторичные конечные точки (3)
  • hemodynamic parameters 1 [Срок оценки: 01.09.2025-10.01.2026]
  • hemodynamic parameters 2 [Срок оценки: 01.09.2025-10.01.2026]
  • hemodynamic parameters 3 [Срок оценки: 01.09.2025-10.01.2026]

Критерии участия

Критерии включения

  • Patients over 18 years of age
  • Patients undergoing below-knee lower extremity surgery
  • Patients with ASA classifications I, II, III, and IV
  • Patients who have consented before the procedure
  • Patients who are literate and able to give consent

Критерии исключения

  • Patients in whom regional anesthesia is contraindicated
  • Patients who refuse to participate in the study

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara Bilkent City Hospital — Ankara

Публикации

  • Park J, Hyeon CW, Lee SH, Kim J, Kwon JH, Yang K, Min JJ, Lee JH, Lee SM, Yang JH, Song YB, Hahn JY, Choi JH, Choi SH, Kim K, Ahn J, Gwon HC. Mildly Elevated Cardiac Troponin below the 99th-Percentile Upper Reference Limit after Noncardiac Surgery. Korean Circ J. 2020 Oct;50(10):925-937. doi: 10.4070/kcj.2020.0088. Epub 2020 Jul 24. PMID 32812403
  • Horr S, Reed G, Menon V. Troponin elevation after noncardiac surgery: Significance and management. Cleve Clin J Med. 2015 Sep;82(9):595-602. doi: 10.3949/ccjm.82a.15076. PMID 26366956
  • Devereaux PJ, Szczeklik W. Myocardial injury after non-cardiac surgery: diagnosis and management. Eur Heart J. 2020 May 1;41(32):3083-3091. doi: 10.1093/eurheartj/ehz301. PMID 31095334

Идентификаторы

NCT: NCT07241572 · E2-25-11354

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗