Меню
Идёт набор NCT06726811

Droperidol and QTc Interval Changes in ED Patients

— Наблюдательное Emergency Department Patient QTc Intervals Changes

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: Droperidol injection.
Кому может быть актуально
Состояния в реестре: Emergency Department Patient, QTc Intervals Changes. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Low-Dose Droperidol and Its Association with QTc Interval Changes in Emergency Department Patients

Обзор

Objectives To assess the association of low-dose Droperidol administration in the emergency department with changes in the QTc interval. Hypothesis Our study is designed to test the null hypothesis that there will be no clinically significant change in QTc interval after administration of 2.5mg of IV Droperidol during an emergency department visit.

Подробное описание

The investigators plan to conduct ECG evaluation for QT interval both before and after patients are given 2.5 mg of droperidol. Specifically, a convenience sample of consenting adult patients, ages 18 years and older, who present to the ED, and are in a cardiac-monitored bed in the ED who, at the discretion of their treating physician, have an ECG recorded and then receive a dose of 2.5 mg of droperidol IV will be enrolled in our study. The investigators will then have a second ECG printed at least 5 minutes and no more than 30 minutes after the droperidol is given. Change in QT interval between the two ECGs will be documented. It may be necessary to review the EMR in order to document the time of droperidol administration.

These post-droperidol ECGs will not be stored in the electronic medical record nor read by a physician in real time. Treatment decisions regarding the patient's medical care in the ED will not be affected by these second ECGs; decisions about whether other ECGs may be needed will be made by the treating physician. The primary study outcome will be the percentage of the study population who experience a clinically significant increase in QTc after low-dose droperidol administration, defined as an increase in QTc of 20 ms or greater. Secondary outcome measures will be the mean change in QTc across the study population, and the percentage of the study population for whom the administration of low-dose droperidol is associated with an increase in QTc that re-classifies them as having a prolonged QTc (\>450 ms in men and \>470 ms in women).

Вмешательства

  • Препарат Droperidol injection
    2.5 mg

Первичные конечные точки

  • ECG Evaluation [Срок оценки: 30 minutes after Droperidol is given.]

Критерии участия

Критерии включения

  • ED patients ages 18 years or older in a cardiovascular-monitored bed who have both an ECG and a 2.5 mg dose of IV droperidol ordered by their treating physician will be eligible for inclusion.

Критерии исключения

  • Refusal to provide consent.
  • Administration of droperidol before the first ECG is performed.
  • Inability to complete the consent form and questionnaire due to clinical instability, severe pain, or disorientation as determined by a study physician.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • CHRISTUS Spohn Hospital Corpus Christi-Shoreline — Corpus Christi

Публикации

  • White PF. Droperidol: a cost-effective antiemetic for over thirty years. Anesth Analg. 2002 Oct;95(4):789-90. doi: 10.1097/00000539-200210000-00001. No abstract available. PMID 12351246
  • Trinkley KE, Page RL 2nd, Lien H, Yamanouye K, Tisdale JE. QT interval prolongation and the risk of torsades de pointes: essentials for clinicians. Curr Med Res Opin. 2013 Dec;29(12):1719-26. doi: 10.1185/03007995.2013.840568. Epub 2013 Sep 23. PMID 24020938
  • Pickham D, Helfenbein E, Shinn JA, Chan G, Funk M, Weinacker A, Liu JN, Drew BJ. High prevalence of corrected QT interval prolongation in acutely ill patients is associated with mortality: results of the QT in Practice (QTIP) Study. Crit Care Med. 2012 Feb;40(2):394-9. doi: 10.1097/CCM.0b013e318232db4a. PMID 22001585
  • Nachimuthu S, Assar MD, Schussler JM. Drug-induced QT interval prolongation: mechanisms and clinical management. Ther Adv Drug Saf. 2012 Oct;3(5):241-53. doi: 10.1177/2042098612454283. PMID 25083239
  • Jackson CW, Sheehan AH, Reddan JG. Evidence-based review of the black-box warning for droperidol. Am J Health Syst Pharm. 2007 Jun 1;64(11):1174-86. doi: 10.2146/ajhp060505. PMID 17519460
  • Haddad PM, Anderson IM. Antipsychotic-related QTc prolongation, torsade de pointes and sudden death. Drugs. 2002;62(11):1649-71. doi: 10.2165/00003495-200262110-00006. PMID 12109926
  • Domino KB, Anderson EA, Polissar NL, Posner KL. Comparative efficacy and safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting: a meta-analysis. Anesth Analg. 1999 Jun;88(6):1370-9. doi: 10.1097/00000539-199906000-00032. PMID 10357347
  • Charbit B, Albaladejo P, Funck-Brentano C, Legrand M, Samain E, Marty J. Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron. Anesthesiology. 2005 Jun;102(6):1094-100. doi: 10.1097/00000542-200506000-00006. PMID 15915019

Идентификаторы

NCT: NCT06726811 · 2025-026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗