Interest of the Automated Management of Deep Neuromuscular Blockade Monitoring : A Pilot Pre-post Quasi Experimental Study (CURATP)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluate the monitoring of deep NMB by automated management of the measurement of depth NMB (ATP mode) compared to non-automated monitoring (PTC/TOF) in order to improve the maintenance of deep NMB during abdominal surgery
研究概览
简要总结
Neuromuscular blockade (NMB) recommendations updated in 2018 by the Société Française d'Anesthésie et Réanimation (SFAR) recommend the use of NMB agents to facilitate surgical procedure during abdominal surgery by laparotomy or laparoscopy.
This study aims to evaluate deep NMB monitoring with automated management of NMB depth measurement (ATP mode) versus non-automated monitoring (PTC/TOF), in order to improve the maintenance of deep NMB during abdominal surgery.
详细描述
The beneficial effects of deep NMB on the surgical conditions and thus the per and post operative surgical morbidity have been demonstrated in several studies, but the evidence are not yet consistent enough to make recommendations.
The monitoring of per operative NMB remains the rule, using the Train Of Four (TOF) at the ulnar nerve at the adductor of the thumb. However, when deep NMB for the most resistant muscles of the body is required (diaphragm and abdominal wall), the Post Tetanic Count (PTC) should be used.
In order to better adjust the NMB to the conditions of muscle relaxation required during surgery, an automatic mode called ATP for Automatic TOF/PTC has been developed (TofScan, Idmed, Marseille, France).
The investigators hypothesized that the use of the ATP would be able to better insure deep NMB, and to limit interventions on patients and/or on the NMB monitor during surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Masking only for the anesthesist in arms "Time 1"
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
- •Patients will be included if they meet all the following criteria :
- •Age ≥ 18 years
- •Scheduled Abdominal surgery by laparoscopy (digestive, urological and gynaecological) with a planned procedure duration of more than one hour, requiring deep NMB by rocuronium
- •ASA I, II or III
- •Free subject, without guardianship, curatorship or subordination
- •Signed informed consent
排除标准
- •Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
- •Induction in rapid sequence,
- •Use of an other NMB agent than rocuronium
- •Predictable difficult intubation
- •Persons participating in another clinical trial
结局指标
主要结局
Evaluate the monitoring of deep NMB by automated management of the measurement of depth NMB (ATP mode) compared to non-automated monitoring (PTC/TOF) in order to improve the maintenance of deep NMB during abdominal surgery
时间窗: From intubation to surgical closure
Percentage of time spent on deep NMB target during anesthesia, defined by PTC ≥ 1 and ≤ 5 responses
次要结局
- Effect of maintaining deep NMB at surgical level during the procedure(From intubation to surgical closure)
- Number of interventions by the anesthesia team to maintain deep curarization(From intubation to surgical closure)
- Amount of NMB agents administered(From intubation to surgical closure)
- Need to reverse NMB agents at the end of the procedure(From intubation to surgical closure)
- Surgical conditions on the Leiden Surgical Rating Scale score(From intubation to surgical closure)