A Blinded Randomized Study of Ephedrine 0.15 mg/kg for Reducing Onset Time of Rocuronium 0.6 mg/kg in Elderly Patients (≥ 80 Years)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Onset time of rocuronium 0.6 mg/kg defined as the time from administration of rocuronium until TOF count of 0.
研究概览
简要总结
The aim of this study is to determine the onset time of rocuronium after administration of ephedrine 0.15 mg/kg in patients with age ≥ 80 years. The hypothesis of this study is that ephedrine 0.15 mg/kg provides a shorter onset time compared to placebo (saline).
详细描述
Numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications. Aging leads to a progressive impairment of organ function and a decline in physiologic reserve and in the elderly patient population, pharmacodynamics and pharmacokinetics of medications administered during anesthesia may be influenced by the age-related reduction in cardiac output, liver function and renal function. Also, the body composition changes with age and elderly have lower total body water and an increase in body fat.
Neuromuscular blocking agents (NMBAs) are administered during anesthesia to facilitate tracheal intubation. However, in elderly patients onset time of standard doses of NMBAs are prolonged, and for 0.6 mg/kg of rocuronium it is prolonged by 50% when comparing elderly with younger adults (median 135 seconds vs 90 seconds). A prolonged onset time of rocuronium may result in prolonged time to tracheal intubation which aims to secure the patients airway and breathing during anesthesia and thereby prevents pulmonary aspiration and hypoxia. It is therefore relevant to investigate measures to reduce onset time of rocuronium in the elderly.
Ephedrine administered in younger adults undergoing general anesthesia has reduced the onset time of rocuronium 0.6 mg/kg. The mechanism behind this is speculated to be an increase in cardiac output.
It is possible to detect onset time of NMBAs with objective neuromuscular monitoring perioperatively by train-of-four (TOF) stimulation at the ulnar nerve. The effect of ephedrine on onset time of rocuronium has not been assessed in elderly patients above 80 years of age.
The possible benefit of this trial is to investigate whether ephedrine 0.15 mg/kg reduces onset time of rocuronium 0.6 mg/kg in the elderly. This may result in a shorter time to tracheal intubation and also establish better intubating conditions. The results may help to detect the optimal method for administering rocuronium to facilitate tracheal intubation in elderly patients.
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, Outcomes Assessor)
盲法说明
- The surgeon will be blinded to treatment group allocation during the induction.
- The anesthesia personnel will be blinded to treatment group allocation during induction and intubation, but after gathering the data, they will be unblinded.
- The investigator controlling the nerve stimulator will be blinded throughout the whole procedure.
- Surgical personnel will be blinded to treatment group allocation during induction.
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 for elective operations under general anesthesia with intubation
- •American Society of Anesthesiologists physical status classification (ASA) I to III
- •Informed consent
- •Read and understand Danish
排除标准
- •Known allergy to rocuronium or ephedrine
- •Neuromuscular disease that may interfere with neuromuscular data
- •Indication for rapid sequence induction
- •Daily use of beta-blocking agents
- •Known cardiac arrythmia (atrial fibrillation, supraventricular or ventricular)
研究组 & 干预措施
Saline group
Saline 1 ml.
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
Ephedrine group
Ephedrine 0.15 mg/kg. Dose of ephedrine is based on ideal body weight, calculated as height (cm) minus 105 for women and height (cm) minus 100 for men or actual body weight, whichever is lower.
干预措施: Ephedrine Hydrochloride 30 mg/ml (Drug)
结局指标
主要结局
Onset time of rocuronium 0.6 mg/kg defined as the time from administration of rocuronium until TOF count of 0.
时间窗: Within 1 hour
Onset time is determined by an investigator using a stop-watch.
次要结局
- Intubating conditions assessed by The Intubation Difficulty Scale (IDS)(Within 1 hour)
- Intubating conditions assessed by Fuchs-Buder scale(Within 1 hour)
- Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes after administration of ephedrine or saline)(Within 15 minutes)
- Change in mean arterial blood pressure from before induction to immediately after intubation(Within 1 hour)
- Time to TOF 0.9(Within 4 hours)
研究者
Matias Vested
Principal Investigator, Medical Doctor, PhD
Rigshospitalet, Denmark