An Observational Study of Cisatracurium 0.15 mg/kg, Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Young (18 - 40 Years) and Elderly (≥ 80 Years) Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Onset time
研究概览
简要总结
The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.
详细描述
The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. The hypothesis of this study is that cisatracurium administered in elderly patients (>80 years) has a longer onset time and duration of action compared to younger patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 80 or ≥18 - ≤40 years of age
- •Informed consent
- •Scheduled for elective surgery under general anaesthesia (expected duration of anaesthesia > 1 hour) with intubation and use of cisatracurium
- •American Society of Anaesthesiologists (ASA) physical status classification I to III
- •Can read and understand Danish
排除标准
- •Known allergy to cisatracurium
- •Neuromuscular disease
- •Indication for rapid sequence induction
- •Surgery in the prone position
研究组 & 干预措施
Elderly
patients aged 80 years or older
干预措施: Cisatracurium (Drug)
young
patients aged 18-40 years
干预措施: Cisatracurium (Drug)
结局指标
主要结局
Onset time
时间窗: within 10 minutes after administration
the time from the start of the injection of cisatracurium to train-of-four (TOF) count of 0 monitored by acceleromyography
次要结局
- Duration of action(within 120 minutes after administration of cisatracurium)
- intubation conditions(within 10 minutes after administration of cisatracurium)
- Laryngeal morbidity(24 hours after surgery)
- Amount of ephedrine or metaoxedrine administered(within 10 minutes after administration of cisatracurium)
研究者
Matias Vested
MD
Rigshospitalet, Denmark