Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Time from verified correct tube placement after intubation to spontaneous respiration, defined as respiration frequency of >8/minute, tidal volume >3ml/kg and a saturation of >90% for 30 seconds.
研究概览
简要总结
Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol.
Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgical patients with a planned rapid sequence induction of anaesthesia.
- •Informed consent.
- •Legally competent.
- •Be able to understand Danish and be able to read the given information in Danish.
- •Females can only participate if they have reached menopause, have had hysterectomy performed, use a coil as birthcontrol, or if they are sterilized.
排除标准
- •Presence of kidney disease, defined as S-creatinine >0,200 mmol/L.
- •Known lung or heart disease, defined as NYHA-class >2 or CCS-class >
- •Known allergic reactions to Rocuronium, Suxamethon, Propofol or Sugammadex.
- •Contraindications to Suxamethon. Including raised P-potassium (>5,0 mmol/L), untreated glaucoma, neuromuscular disorders or disposition to malignant hyperthermia.
- •Body mass index of >35 kg/m
- •Pregnant.
- •Breastfeeding.
研究组 & 干预措施
Rocuronium-Sugammadex
干预措施: Rocuronium-Sugammadex (Drug)
Succinylcholine
干预措施: Succinylcholine (Drug)
结局指标
主要结局
Time from verified correct tube placement after intubation to spontaneous respiration, defined as respiration frequency of >8/minute, tidal volume >3ml/kg and a saturation of >90% for 30 seconds.
时间窗: 20 minutes
次要结局
- Duration of action. Measured as the time from administration of the neuromuscular blocking agent to the T1-value in Train-of-Four (TOF) returns to >90% of T1-max.(20 minutes)
- Intubation Difficulty Scale (IDS)(20 minutes)
- Intubation conditions(20 minutes)
- Side effect - Muscle ache.(Postoperative (within 24 hours))
- Side effect - Tachycardia (>100 beats per minute).(20 minutes)
- Side effect - Bradycardia (<50 beats per minute).(20 minutes)
- Side effect - Awareness/recall. Evaluated by modified Brice Questionaire.(Postoperative (within 24 hours))