A Pilot Study to Evaluate if Caffeine Helps Children With Obstructive Sleep Apnea Recover Faster From Anesthesia, and With Less Complications After General Anesthesia for Tonsillectomy and Adenoidectomy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.
研究概览
简要总结
This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).
详细描述
Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively.
Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA.
The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T & A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital.
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
- 30 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 2.5-18 years old
- •Diagnosed with obstructive sleep apnea
- •Undergoing elective tonsillectomy and adenoidectomy
排除标准
- •Age below 2.5 or above 18 years
研究组 & 干预措施
Placebo
Saline
干预措施: Placebo (Drug)
Caffeine
Caffeine benzoate
干预措施: Caffeine (Drug)
结局指标
主要结局
Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.
时间窗: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation \<95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.
次要结局
- Occurence of Post Extubatory Respiratory Adverse Events.(Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.)
- Extubation Time.(Duration from anesthesia end until extubation time.)
- Awakening Time(Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.)
- Post Anesthesia Care Unit (PACU) Duration(Time spent in PACU following surgical procedure prior to discharge home or hospital admission.)
- Hospital Discharge Time(Total time from end anesthesia to discharge home)
研究者
Samia Khalil
Professor
The University of Texas Health Science Center, Houston