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Набор скоро начнётся NCT06844201

Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine

— Наблюдательное Ephedrine Norepinephrine Postoperative Delirium (POD)

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: Ephedrine, Norepinephrine.
Кому может быть актуально
Состояния в реестре: Ephedrine, Norepinephrine, Postoperative Delirium (POD). Базовые параметры: Без ограничений · 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
Список центров уточняется — проверьте первичный протокол.
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

Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine: a Retrospective TriNetX Database Study

Обзор

This retrospective study aims to investigate the effects of norepinephrine compared to ephedrine, administered on the day of surgery, on the incidence of postoperative delirium.

Подробное описание

This retrospective analysis will be conducted using data from the TriNetX US Collaborative Network. This study was designed to assess the impact of intraoperative norepinephrine versus intraoperative ephedrine use on postoperative delirium. Inclusion criteria includes patients who underwent surgery (CPT code 1003143) and were either administered ephedrine or norepinephrine on the day of surgery and did not receive both vasopressors on the day of surgery. Exclusion criteria exclude patients who underwent neurology and neuromuscular surgery, cardiac surgery, and cardiac procedures; patients who were administered epinephrine or dopamine on the day of surgery; patients who were administered ephedrine or norepinephrine at any time within the 7 days following the day of surgery to account for patients that might have required pressor infusions for other causes; or a prior history of disorientation (ICD-10 code R41.0) or unspecified dementia (F03).

Propensity score matching through TriNetX will be used to adjust for age, sex, race, BMI, and comorbidities including cerebrovascular disease (ICD-10 code I60-I69), chronic heart failure (I11.0), primary hypertension (I10, I11.9), chronic obstructive pulmonary disease (COPD) (J42, J43, J44, J47), asthma (J45), chronic kidney disease (CKD) (I12, I13), diabetes mellitus (E08-E13), depression (F32.A), schizoaffective disorders (F25), alcohol and drug abuse (F10.1, F10.2, Z71.4), smoking status (F17.2, F17.21), and history of antipsychotic (CN700) and benzodiazepine (C302) usage.

Independent t-tests and chi-squared tests will be used to compare postoperative delirium across the cohorts. To evaluate the relationship between norepinephrine and postoperative delirium versus ephedrine and postoperative delirium, risk differences, and risk ratios with 95% CIs will be calculated following propensity score matching. The TriNetX platform will be used for all analyses, with p \< 0.05 representing statistical significance.

Вмешательства

  • Препарат Ephedrine
    Received ephedrine the same day of surgery.
  • Препарат Norepinephrine
    Received norepinephrine the same day of surgery.

Первичные конечные точки

  • Postoperative delirium [Срок оценки: Within 7 days following surgery.]

Критерии участия

Ephedrine group:

Критерии включения

  • underwent surgery (CPT code 1003143)
  • administered ephedrine on the day of surgery

Критерии исключения

  • received both vasopressors (ephedrine and norepinephrine) on the day of surgery.
  • patients who underwent neurology and neuromuscular surgery, cardiac surgery, and cardiac procedures
  • patients who were administered epinephrine or dopamine on the day of surgery
  • patients who were administered ephedrine or norepinephrine at any time within the 7 days following the day of surgery
  • a prior history of disorientation (ICD-10 code R41.0) or unspecified dementia (F03)

Norepinephrine group:

Критерии включения

  • underwent surgery (CPT code 1003143)
  • administered norepinephrine on the day of surgery

Критерии исключения

  • received both vasopressors (ephedrine and norepinephrine) on the day of surgery.
  • patients who underwent neurology and neuromuscular surgery, cardiac surgery, and cardiac procedures
  • patients who were administered epinephrine or dopamine on the day of surgery
  • patients who were administered ephedrine or norepinephrine at any time within the 7 days following the day of surgery
  • a prior history of disorientation (ICD-10 code R41.0) or unspecified dementia (F03)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06844201 · Ephedrine vs Norepinephrine

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗