Impact of Intravenous Lidocaine on Laryngeal Reflex Responses in Pediatric Patients Anesthetized With Propofol
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Occurence of laryngospasm (defined as complete adduction of vocal cords and/or fals cords) with apnea lasting >10sec after laryngeal stimulation
研究概览
简要总结
To describe respiratory and laryngeal responses to laryngeal stimulation during propofol anesthesia in children. To determine whether the co-administration of lidocaine blunts these reflex responses. The outcome of primary interest is the reflex laryngospasm.
Hypotheses:
I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv. administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol (3mcg/ml).
II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv. administration of lidocaine is equivalent to the response before the administration of lidocaine.
详细描述
Based on our previous work assessing the laryngeal reflex responses in children, the use of propofol appears to be promising regarding a low incidence of laryngospasm. Compared with a sevoflurane-based anesthesia, the incidence was found to be significantly lower, but there is a high incidence of other reflex responses, such as coughing and expiration reflexes. The use of lidocaine has been advocated to reduce the incidence of laryngospasm in anesthetized children. However, based on clinical studies its effectiveness in the prevention or attenuation of laryngospasm is controversial.
In a previous work using a established stimulation model (stimulating the laryngeal mucosa with a small amount of distilled water under direct fiberbronchoscopic observation), we observed a risk reduction of 60% of laryngospasm 2min. after the application of 2mg/kg bolus of lidocaine. This effect had already diminished after 10 min.
The laryngeal reflex responses differ largely in children anesthetized with either inhalational anesthetics or with propofol. The impact iv administered lidocaine on laryngeal and respiratory reflex responses in children anesthetized with propofol has not been assessed, although this combination might result in a profound suppression of laryngeal reflex responses.
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
- 25 Months 至 84 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25 - 84 months
- •gender: female / male
- •elective surgery or diagnostic procedure requiring general anesthesia
排除标准
- •respiratory infection within the last 2 weeks
- •reactive airway disease under therapy
- •cardiovascular disease
- •neuromuscular disease
- •positive family history of malignant hyperthermia
- •known hypersensitivity to the investigational medical product
- •Participation in another study
- •Inability of the parents to read and understand the participant's information
研究组 & 干预措施
larynx assessment under stimulation
干预措施: NaCl 0,9% (Drug)
Larynx assessment under stimulation
干预措施: NaCl 0,9% (Drug)
结局指标
主要结局
Occurence of laryngospasm (defined as complete adduction of vocal cords and/or fals cords) with apnea lasting >10sec after laryngeal stimulation
时间窗: 10 min.
次要结局
未报告次要终点
研究者
Thomas Erb
Prof. Dr. Thomas O. Erb
University Hospital, Basel, Switzerland