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临床试验/EUCTR2019-000753-31-FR
EUCTR2019-000753-31-FR进行中(未招募)1 期

Evaluation of REMIFENTANIL as an alternative to curare for rapid sequence anesthetic induction in patients at risk of gastric fluid inhalation - REMICrush

CHU Nantes0 个研究点目标入组 1,150 人开始时间: 2019年5月14日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
CHU Nantes
入组人数
1,150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Female or male.
  • - Aged 18 to 80 years old
  • - Intervention requiring general anesthesia with orotracheal intubation
  • - Anesthetic management with indication of induction in rapid sequence
  • - Risk of gastric fluid inhalation defined by at least one of the following criteria: fasting period < 6:00 am, digestive obstruction, functional ileus, vomiting < 12:00 pm orthopedic trauma < 12:00 pm, history of severe GERD and/or hiatal hernia and/or gastroparesis and/or dysautonomy and/or gastroesophageal surgery
  • - Existence of informed and signed consent from the patient, or in the absence of an emergency procedure
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 850
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 300

排除标准

  • - impossible Intubation planned
  • - Known or suspected history of allergy to curares and/or remifentanil
  • - History of neuromuscular disease contraindicating the use of curares
  • - History of residual curarization
  • - History of malignant hyperthermia
  • - Preoperative respiratory distress (SpO2 < 95% in ambient air)
  • - Preoperative shock (under vasopressor amines)
  • - Patient in cardiorespiratory arrest
  • - A woman of childbearing potential and of childbearing potential who has an ongoing pregnancy and/or clinical signs suggestive of an ongoing pregnancy and/or who does not have a contraceptive or contragestive method and has had unprotected sexual relations within 15 days after the last menstrual period.
  • - Patients under guardianship or curatorship
  • - Intended use of ETOMIDATE for rapid sequence induction

研究者

发起方
CHU Nantes

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