A Single-blinded Multicenter Randomized Interventional Study of Rocuronium 0.3 mg/kg, and 0.9 mg/kg Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Elderly Patients (≥ 80 Years).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Rocuronium onset time
研究概览
简要总结
The number of elderly patients above 80 years is increasing and a large proportion of these patients will require surgery and anesthesia.
During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. There is a risk of residual neuromuscular block when using NMBAs like rocuronium.
The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.
详细描述
The number of elderly patients (>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia within the next decades. Elderly patients are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia.
Rocuronium is a nondepolarizing neuromuscular blocking drug with an onset time of approximately 70 s and a clinical duration of action of approximately 50 min. according to previous studies. During anesthesia rocuronium is administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Rocuronium is primarily metabolized in the liver (70 % unmetabolized via the bile) and excreted via the kidneys.
Onset time and duration of action of rocuronium should be assessed by objective neuromuscular monitoring. Also, this reduces the risk of residual neuromuscular block which is defined as a train of four (TOF) ratio less than 0.9. Especially elderly patients have a high incidence of residual neuromuscular block.
The collected data regarding the effect of rocuronium in elderly patients may change the treatment so these patients receive the correct dose for optimal intubating conditions. Also, detection of duration of action of different doses of rocuronium may reduce the risk of residual block and postoperative respiratory complications
The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to elective surgery (expected duration time of surgery > 1 hour) under general anesthesia with intubation and use of rocuronium.
- •American Society of Anesthesiologists (ASA) physical status classification I to III
- •Informed consent (see appendix 1)
- •Read and understand Danish
排除标准
- •Neuromuscular disease
- •Known allergy to rocuronium
- •Prone position
- •Indication for rapid sequence induction
研究组 & 干预措施
Group receiving rocuronium 0,9 mg/kg
Rocuronium 0,9 mg/kg at induction
干预措施: Rocuronium 0,9mg/kg (Drug)
Group receiving rocuronium 0,3 mg/kg
Rocuronium 0,3 mg/kg at induction
干预措施: Rocuronium 0,3mg/kg (Drug)
结局指标
主要结局
Rocuronium onset time
时间窗: intraoperative (From start of rocuronium injection to train-of-four (TOF) count of 0)
Time from start of rocuronium injection to train-of-four (TOF) count of 0
次要结局
- Evaluation of intubating conditions ad modum Fuchs-Buder et al(intraoperative (From train-of-four (TOF) count of 0 till))
- Duration of action of rocuronium(intraoperative (Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.))
研究者
Matias Vested
Principal Investigator, Anesthesiologist, MD, PhD
Rigshospitalet, Denmark