跳至主要内容
临床试验/NCT00611195
NCT00611195已完成4 期

Impact of Remifentanil Administration on Laryngeal Reflex Responses in Pediatric Patients With Upper Respiratory Anesthetized With Propofol

Thomas Erb1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Occurence of laryngospasm (defined as complete closure of the vocal or false 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 with upper airway infections. To determine whether the co-administration of remifentanil blunts these reflex responses. To test whether the co-administration of remifentanil results in a significant reduction of apnea with laryngospasm in these patients.

Hypotheses:

I: In children with a URI undergoing anesthesia with propofol, the incidence of apnea and laryngospasm after controlled stimulation is expected to occur 2.5 times more frequently than in children without URI (20 vs. 8%).

II: The incidence of apnea and laryngospasm is diminished after administration of remifentanil.

详细描述

Patients undergoing anesthesia in the presence of an upper respiratory infection (URI) are very common in pediatric anesthesia practice. Although, clinical data confirm that children with URIs are at increased risk of perioperative complications, it has become standard practice not to postpone anesthesia in the presence of URI. While complications (such as cough, hypoxemia) can be anticipated, recognized, and treated, laryngospasm remains the most severe and dramatic complication. In clinical practice, patients who develop laryngospasm are greater than 2.5 times more likely to have an active upper respiratory infection; therefore, knowledge that allows for rational selections of anesthetic agents under this condition is highly warranted. Based on our results obtained in healthy children, the use of propofol appears to be most promising under these circumstances. For this reason, the laryngeal and respiratory reflex responses should be assessed in patients with URI anaesthetized with propofol.

Commonly held believes suggest, that the administration of opioids blunts airway reflexes, including laryngospasm. However, in a previous study of our group in children anesthetized with sevoflurane the administration of fentanyl effectively blunted all airway reflexes but laryngospasm. These results are in contrast to those obtained in adults anesthetized with propofol where fentanyl also effectively blunted laryngospasm.

In children the combined use of propofol and remifentanil has become more frequent, particularly because of its synergistic pharmacodynamic effect. Besides its use during surgical procedures, this regime is also being increasingly advocated for diagnostic procedures such as bronchoscopy and esophago-gastroduodenoscopy. These interventions include instrumentation of the airway in children that are at an increased risk of harmful effects of laryngeal reflex responses.

Despite their obvious clinical significance, reflexes that involve the function of the upper airway are only minimally understood and information on such reflexes is scarce in anesthetized humans. Nonetheless, a model was developed by analyzing respiratory variables and endoscopic images after stimulating the laryngeal mucosa with a small amount of distilled water. This model was successfully adapted to the pediatric setting by our group assessing the impact of propofol, sevoflurane, fentanyl and lidocaine administration on laryngeal reflex responses in preschool children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Months 至 84 Months(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I + II
  • elective intervention under general anesthesia
  • acute upper respiratory tract infection

排除标准

  • chronic respiratory tract infection
  • fever >38,3° celsius
  • productive cough
  • neuromuscular disease
  • malignant hyperthermia
  • cardiac disease

研究组 & 干预措施

1

Other

Larynx assessment under stimulation

干预措施: propofol, remifentanil (Drug)

结局指标

主要结局

Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation

时间窗: 5min

次要结局

未报告次要终点

研究者

发起方
Thomas Erb
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Thomas Erb

Prof.Dr. Thomas Erb

University Hospital, Basel, Switzerland

研究点 (1)

Loading locations...

相似试验