Measuring of the Duration of Action of Different Doses of Rocuronium-induced Neuromuscular Block in Infants During Surgical Treatment of Craniosynostosis - a Prospective, Case-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time till TOF ratio of 0.9
研究概览
简要总结
The use of intravenous muscle relaxants during anaesthesia can significantly facilitate endotracheal intubation and reduce the chance of possible airway complications during intubation. Overall, muscle relaxants make anaesthesia safer. Quantitative measurement of neuromuscular block is essential when anaesthesiologists use muscle relaxants. It allows to avoid postoperative residual block complications such as upper airway obstruction, hypoxia, pharyngeal dysfunction, aspiration.
Unfortunately, quantitative monitoring of neuromuscular block is not routinely used in everyday practice - and this is particularly true in the infant and child population. In adults, the relative absence of easy-to-use and reliable monitors has led to the neglect of neuromuscular monitoring. One of the monitoring techniques suitable for this purpose is electromyography. This EMG-based instrument (TetraGraph ® ) measures the action potential of the musculus adductor pollicis or the musculus abductor digiti minimi muscles.
Clinical trials have shown that for quantitative monitoring of the effect of muscle relaxants, extubation is safe if the TOF ratio is 0.9. Some studies have shown that TOF ratio of 0.95 is necessary to reduce the risk of postoperative respiratory complications.
In this study, investigators will use an EMG-based neuromuscular monitor, the TetraGraph ®, and an electrode specially designed for the infant and child population to measure the muscle relaxant (rocuronium) effect of infants undergoing decompressive surgery for craniosynostosis, from the time of induction until the TOF ratio of 0.9 is reached, using inhaled anaesthetic or intravenous agent to maintain anaesthesia.
In adult population it has been clearly demonstrated that inhaled anaesthetics potentiate the effect of muscle relaxants during maintenance anaesthesia, whereas this effect is moderate or negligible when intravenous maintenance agents are used. There is limited literature on the efficacy of rocuronium in the infant population when anaesthesia is maintained with sevoflurane or propofol. The aim of present study is to improve postoperative patient safety in the infant population.
Infants undergoing anaesthesia for elective craniosynostosis surgery are included in the study. The surgical preparation, anaesthesia of the patients, will be carried out in all aspects according to the daily routine, i.e.: All infants will receive 0.1 mg/kg midazolam i.v. for pre-medication. In the operating theatre, a peripheral vein is provided. Precordial ECG, pulse oximetry, blood pressure measurement, end-expiratory CO 2 , end-expiratory oxygen measurement will be performed during the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 12 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 infants whose parents have given informed written consent to participate in the studies;
- •Age: 3-12 months;
排除标准
- •diseases affecting neuromuscular function (myopathies, severe liver and kidney failure);
- •Lack of parental consent
- •Known allergy to any of the products used
研究组 & 干预措施
Effect of inhaled anaesthetics on muscle relaxants
Duration of action of rocuronium bromide under anaesthesia maintained with Sevoflurane
干预措施: Sevofluorane (Drug)
Effect of intravenous anaesthetics on muscle relaxants
Duration of action of rocuronium bromide under anaesthesia maintained with Propofol
干预措施: Propofol (Drug)
结局指标
主要结局
Time till TOF ratio of 0.9
时间窗: From administration of rocuronium to achieve TOF ratio 0.9, during a surgical procedure due to craniosynostosis.
The primary end point will be to compare the time needed to reach TOFR 0.9 after a single, 0.6 mg/kg dose of rocuronium in anaesthesia maintained by propofol and sevoflurane
次要结局
- Time til TOF count 1, 2, 3, 4(From the administration of rocuronium to achieve TOF count 1, 2, 3, 4, during a surgical procedure due to craniosynostosis.)
研究者
Tamas Vegh, MD
MD PhD assistant professor, Head Division of General, Transplantation, Vascular and Thoracic Anesthesia
University of Debrecen
