The Frequency of Airway Complications After LMA Removal in Children: A Comparison of TIVA and Sevoflurane
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Respiratory adverse outcomes
研究概览
简要总结
Background: The removal of Laryngeal Mask Airway (LMA) in children may be associated with respiratory adverse events. The incidence of these adverse events may be influenced by the type of anesthesia maintenance. It is not clear whether Total Intravenous Anesthesia (TIVA) with propofol is associated with a lower incidence of respiratory events upon removal of LMA as compared to maintenance with sevoflurane.
Specific Aim: The primary aim of this study is to compare the prevalence of respiratory adverse events following LMA removal in patient receiving TIVA versus sevoflurane inhalational anesthesia in a pediatric population aged between 6 month and 6 years old. Secondary outcomes include quality of induction, maintenance and emergence from anesthesia between the 2 groups as evidenced by ease of LMA insertion, absence of bucking or movement during the procedure, time to LMA removal, and absence of emergence agitation.
Methods: In this prospective randomized clinical trial, children will be enrolled in one of two groups: Group 1 will receive propofol for induction and maintenance of anesthesia, Group 2 will receive sevoflurane for induction and maintenance of anesthesia. In both groups patients will be mechanically ventilated. At the end of the procedure, LMAs will be removed when patients are fully awake as defined by the return of reflexes, eye opening, and purposeful movements.
Significance: Data comparing the influence of TIVA and sevoflurane on the occurrence of respiratory adverse events after LMA removal are limited. Both techniques are standard of care at our institution. However, as per our clinical observations, we hypothesize that TIVA is superior to sevoflurane. This study will identify the technique that provides optimal anesthetic conditions and improved patient's safety.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6 months to 6 years old
- •Patients undergoing short duration procedure ( ˂ 2 hours) (such as polysite removal, closed reduction, eye examination, excluding thoracic and abdominal surgery)
- •American Society of Anesthesiologists (ASA): I-III
- •Patients undergoing LMA general anesthesia. (NPO, short procedures, patient without known airway abnormalities).
- •Parental consent
排除标准
- •Age: more than 6 years old and less than 6 months
- •Patients having: Asthma, hyper reactive airway (Acute exacerbation)
- •Patients having recent respiratory tract infection within 2 weeks.
- •Patients with congenital heart disease
- •Patients not eligible for LMA (full stomach, hiatal hernia, known or predicted difficult airway, syndromic patient with facial or airway malformation, patient undergoing major abdominal or thoracic surgery)
- •Patients at high risk of aspiration
- •Anticipated difficult airway
- •Patient with neurologic disorders (children with known neurologic disorders: seizure, mental retardation, cerebral palsy)
- •Difficult LMA insertion (> 3 attempts)
研究组 & 干预措施
Total intravenous anesthsia
Patients in this group will receive Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance.
干预措施: Propofol (Drug)
Sevoflurane
Patients in this group will receive sevoflurane 8% and fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Respiratory adverse outcomes
时间窗: 2 hours
Encountered respiratory adverse outcomes such as cough
次要结局
- Time to emergence(2 hours)
- LMA insertion characteristics(2 hours)
- Quality of anesthesia(2 hours)
- Emergence agitation(2 hours)
研究者
Jean berezian
Instructor of clinical Anesthesiology
American University of Beirut Medical Center