Comparison Between the Neuromuscular Blockade Onset Monitoring and the Expectation of a Fixed Delay After Curarization on the Quality of Laryngoscopy During Intubation in Elective Surgery (MONITURARE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.
研究概览
简要总结
During anesthetic induction, the relevance of neuromuscular blockade (NMB) onset monitoring cannot be asserted and its superiority over waiting for a fixed delay (corresponding to pharmacokinetic knowledge of the neuromuscular blocking agent used) has not been proven. However, many studies have shown a large inter-individual variability on the delay of the NMB onset. The main objective of othe investigator's study is to compare the quality of laryngoscopy during intubation between the NMB onset monitoring and the expectation of a fixed delay after curarization
详细描述
French guidelines on curarization, updated in 2018, do not recommend the NMB onset monitoring due to a lack of data in the literature. Thus, the interest of monitoring cannot be asserted and its superiority over waiting for a fixed delay has not been proven.
Due to a large inter-individual variability on the delay of the NMB onset after administration of atracurium, the relevance of monitoring NMB during an anesthetic induction should be assessed to improve the quality of laryngoscopy.
In case of monitoring, the experts recommend monitoring the NMB onset at the corrugator supercilli because it reflects neuromuscular blockade at the laryngeal adductor muscles.
During the pre-anaesthetic visit, patients will be enrolled after inform consent.
Patients will be randomized in two groups, control group (waiting for a 3-minute delay after injection of atracurium) or monitoring group (waiting for the TOF ratio at 0 at the corrugator supercilli).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years), both sexes
- •Any elective surgery requiring injection of atracurium
- •Free patient, without guardianship or subordination
- •Patients with a social security coverage
- •Informed and signed consent after clear and fair information
排除标准
- •Rapid sequence induction
- •Predictable difficult intubation
- •Use of a neuromuscular blockade agent other than atracurium
- •Known contraindication to a neuromuscular blockade agent
研究组 & 干预措施
Control group
waiting for a 3-minute delay after injection of the atracurium before laryngoscopy
Monitoring group
waiting for the TOF ratio at 0 at the corrugator supercilli before laryngoscopy
干预措施: Monitoring (Device)
结局指标
主要结局
The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.
时间窗: Few minutes after intubation (about 5 minutes)
The primary endpoint is the assessment of the Copenhagen score modified collected during the anesthetic induction after the intubation.
次要结局
未报告次要终点