Intubation Conditions After Rapid Sequence Induction Using Different Doses of Rocuronium with Ephedrine Pretreatment: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Intubation conditions
研究概览
简要总结
This trial will study if ephedrine pretreatment before low doses of rocuronium (0.6 or 0.8 mg/kg) would provide similar intubating conditions as with the high dose of 1.2 mg/kg in patients undergoing RSII.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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
- •ASA physical status I or II
排除标准
- •Neuromuscular disease: myopathies
- •On drugs that interact with the neuromuscular junction or ephedrine
- •Cardiovascular disease: hypertension or ischemic heart disease
- •Increased risk of pulmonary aspiration:
- •Pregnancy
- •Anticipated airway difficulties:
- •Mallampati grade III or IV
- •Obesity (BMI ≥30 kg/m2),
- •Hypersensitivity to any of the study drugs
研究组 & 干预措施
ER6
to receive rocuronium 0.6 mg/kg with ephedrine pretreatment
干预措施: Ephedrine (Drug)
ER6
to receive rocuronium 0.6 mg/kg with ephedrine pretreatment
干预措施: Rocuronium 0.6 (Drug)
ER8
to receive rocuronium 0.8 mg/kg with ephedrine pretreatment
干预措施: Ephedrine (Drug)
ER8
to receive rocuronium 0.8 mg/kg with ephedrine pretreatment
干预措施: Rocuronium 0.8 (Drug)
R12
to receive rocuronium 1.2 mg/kg with no pretreatment
干预措施: Rocuronium 1.2 (Drug)
结局指标
主要结局
Intubation conditions
时间窗: after 60 seconds of rocuronium administration
Evaluation of intubation conditions after rapid sequence induction using rocuronium 0.6 or 0.8 mg/kg with ephedrine pretreatment, compared with 1.2 mg/kg, according to the criteria of the Good Clinical Research Practice (GCRP) in pharmacodynamic studies of NMBAs (Fuchs-Buder et al., 2007), which assess each of the following variables for their qualities described as: (excellent, good, poor) * ease of laryngoscopy (easy, fair, difficult) * vocal cords position (abducted, intermediate, closed) * reaction to tracheal tube insertion and cuff inflation (coughing: none, slight, vigorous) The 3 variables will be combined to describe intubation conditions as: * Excellent: if all qualities are excellent * Good: if all qualities are either excellent or good * Poor: if there is a single poor quality
次要结局
- Mean arterial pressure(every minute of the first 5 minutes of intubation)
- Heart rate(every minute of the first 5 minutes of intubation)
研究者
Amal Ahmed Eldemohi
Resident of Anesthesiology
Ain Shams University