Randomized Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Cardiac frequency (beats per minute)
研究概览
简要总结
The primary objective is to determine whether, during a rapid sequence intubation by etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2 different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous reactional tachycardia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring rapid sequence intubation for whatever reason. This includes the following: a full stomach, obesity, diabetic gastroparesis, gastroesophageal reflux
- •Patient able to give informed consent, and sign the consent.
排除标准
- •Contraindication for the use of any drugs used (regardless of the patient group): a history of serious side effects, allergic reaction
- •Morbid obesity (Body Mass Index > 40)
- •Emergency situation with unstable hemodynamics, and stabilization is impossible before induction
- •Inclusion in another research project within the past 3 months
- •The patient is not insured or beneficiary of a health insurance plan (for the French centers)
- •Patient under guardianship of any kind
- •Patient unable to give informed consent
- •Refusal to sign the consent form
研究组 & 干预措施
0.5 µg / kg remifentanil
Induction anesthesia includes 0.5 µg/kg remifentanil in addition to classic induction anesthesia protocol.
干预措施: 0.5 µg/kg remifentanil (Drug)
1.0 µg/kg remifentanil
Induction anesthesia includes 1.0 µg/kg remifentanil in addition to the classic induction protocol.
干预措施: 1.0 µg/kg remifentanil (Drug)
NaCl
An equivalent volume (1 ml for 10 kg of weight) of isotonic 0.9% NaCl is injected in addition to the classic anesthesia induction protocol
干预措施: NaCl (Drug)
结局指标
主要结局
Cardiac frequency (beats per minute)
时间窗: 15 minutes
Patient cardiac frequency (beats per minute) at the time of induction
次要结局
未报告次要终点