A Single-blinded Multicenter Randomized Study Comparing Intubating Conditions After Either Rocuronium 0.6 mg/kg or Remifentanil 2 µg/kg in Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Evaluation of intubating conditions ad modum Fuchs-Buder et al
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.
Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.
It is unknown which is superior concerning intubating conditions in elderly patients. Therefore, the aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.
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.
During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Studies suggests that avoidance of neuromuscular blocking agents (NMBAs) increases the risk of difficult tracheal intubation and leads to impaired intubating conditions with direct laryngoscopy. Furthermore, avoidance of NMBA significantly increases the risk of upper airway discomfort or injury. Even low doses of rocuronium may be associated with a significant improvement of intubating conditions.
Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.
The possible benefit in this trial is to investigate whether rocuronium 0.6 mg/kg or remifentanil 2 µg/kg provides best intubating conditions in the elderly. This may result in different intubating difficulty scores between the two groups of elderly patients. The results may help to detect the optimal method for intubation of the trachea in elderly patients.
The aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.
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 for elective operations (expected duration of anesthesia > 1 hour) under general anesthesia with intubation
- •American Society of Anesthesiologists physical status classification (ASA) I to III
- •Informed consent (see appendix 1)
- •Read and understand Danish
排除标准
- •Neuromuscular disease
- •Known allergy to rocuronium, remifentanil or sugammadex
- •Rapid sequence induction
研究组 & 干预措施
Group receiving rocuronium at induction
Rocuronium 0,6 mg/kg at induction
干预措施: Rocuronium 0.6 mg/kg (Drug)
Group receiving remifentanil at induction
Remifentanil 2 μg/kg at induction
干预措施: Remifentanil 2 µg/kg (Drug)
结局指标
主要结局
Evaluation of intubating conditions ad modum Fuchs-Buder et al
时间窗: 2 minutes after start of administration of trial medication
Occurrence of excellent intubating conditions 2 minutes after start of administration of 0.6 mg/kg rocuronium or 2 µg/kg remifentanil, scored according to Fuchs-Buder et al. The intubating conditions will be classified as excellent if all qualities are excellent, good if all qualities are either excellent or good and poor if the presence of a single quality is listed as poor.
次要结局
- Subjective side effects of laryngoscopy(24 hours postoperatively and 3 days postoperatively)
- Dose of ephedrine or dose of metaoxedrine administered(From induction until the patient is ready to be positioned for surgery, ranging from 5 minutes up to 1 hour.)
- Intubating conditions according to IDS(2 minutes after start of administration of trial medication)
研究者
Matias Vested
Principal Investigator, Anesthesiologist
Rigshospitalet, Denmark