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
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
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