Addition of Neuromuscular-Blocking Agents During Sevoflurane Induction in Infants : Potential Interest in Reducing Hypoxemia Episodes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 412
- 试验地点
- 6
- 主要终点
- Incidence, expressed as a percentage, of at least on episode of hypoxemia, defined as an arterial oxygen saturation <90%, obtained by continuous measurement of pulse oximetry.
研究概览
简要总结
The prevention of the occurrence of respiratory events is a constant concern in pediatric anesthesia, as these represent the main cause of the anesthesic mortality. These events occur partly during induction of anesthesia and are all the more frequent as the child is young.
The French recommendations do not propose the use of neuromuscular-blocking agents in pediatric anesthesia. This recommendation is controversial In a recently published study, it has been shown that the use of neuromuscular blocking agents during induction in children under 2 years improves intubating conditions and reduces the incidence of hemodynamic and respiratory events. This monocentric study, centered on intubating conditions, does not allow to conclude on the influence of muscle relaxants on reduction of the respiratory morbidity.
The objective of study is to demonstrate that, in children under 2 years, changing the anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia associated with respiratory events occurring during induction
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age <2 years
- •indication of general anesthesia with tracheal intubation
- •inhalational induction scheduled
- •written informed consent of both parents
排除标准
- •contra-indication to inhalational induction (full stomach)
- •contra-indication to the use of rocuronium
- •American Society of Anesthesiologists score (ASA) III or IV
- •intracranial surgery
- •parental refusal
- •absence of affiliation to social security
研究组 & 干预措施
Rocuronium
Intra-venous injection during induction anesthesia of 0.3 mg/kg (1 mL/kg) of rocuronium
干预措施: Rocuronium (Drug)
Placebo
Intra-venous injection during induction anesthesia of 1 mL/kg of sodium chloride 0.9%
干预措施: Sodium chloride 0.9% (Other)
结局指标
主要结局
Incidence, expressed as a percentage, of at least on episode of hypoxemia, defined as an arterial oxygen saturation <90%, obtained by continuous measurement of pulse oximetry.
时间窗: Up to 15 minutes after anesthesia induction
次要结局
- Lowest recorded value of arterial oxygen saturation.(Up to 15 minutes after anesthesia induction)
- Incidence, expressed as a percentage, of at least one episode of bronchospasm(Up to 15 minutes after anesthesia induction)
- Cumulative duration of hypoxemia expressed in seconds and defined as an arterial oxygen saturation <90%(Up to 15 minutes after anesthesia induction)
- Cumulative duration, expressed in seconds, with a decreased in arterial oxygen saturation of 5% as compared to the arterial oxygen saturation at baseline(Up to 15 minutes after anesthesia induction)
- Duration, expressed in seconds, of apnea(Up to 15 minutes after anesthesia induction)
- Incidence, expressed as a percentage, of at least one episode of laryngospasm(Up to 15 minutes after anesthesia induction)