Trial of Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Mean obstruction score at the tongue base
研究概览
简要总结
This research study is designed to learn, first, whether two anesthetics have different effects on collapse seen within the upper airway during sleep endoscopy. A second purpose is to learn whether collapse at several levels of the upper airway is associated with obstructive sleep apnea that persists after adenotonsillectomy, the surgery that removes the tonsils and adenoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A coordinator and anesthesiologist will be unblinded.
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Obstructive sleep apnea (OSA) by the following criteria: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 1.5, confirmed on nocturnal, laboratory-based polysomnography within the previous 12 months scored using American Academy of Sleep Medicine pediatric criteria in an accredited sleep lab.
- •Considered to be a surgical candidate for adenotonsillectomy to treat OSA by an board-certified or board-eligible otolaryngologist.
- •Clinical determination by the child's otolaryngologist surgeon that the child would benefit from sleep endoscopy prior to adenotonsillectomy due to one or more reported risk factors for residual sleep apnea after surgery, which may include:
- •Obese (>95th percentile of body mass index for age)
- •Severe preoperative OSA (AHI ≥10 events/hour)
- •Discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity;
- •African American race
- •Age ≥7 years old
- •Male or Female ages 3.00 - 11.99 years of age at the time of consent
- •Parent/guardian ability to understand and willingness to sign a written informed consent..
- •Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires.
排除标准
- •Previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred >18 months prior to recruitment.
- •Major medical diagnosis that may be exacerbated by the study treatment, pose undue risk to the patient, or that may impact interpretation of study results
- •History of allergic reaction to or contraindication to receiving propofol, dexmedetomidine, ketamine or sevoflurane
- •Allergy to eggs, egg products, soybeans or soybean products.
- •Contraindication to receiving general anesthesia
研究组 & 干预措施
Propofol sedation
2.5 mg/kg loading dose, then continue at an infusion of 250 mcg/kg/minute.
干预措施: Propofol sedation (Drug)
Dexmedetomidine sedation
1 mcg/kg loading dose, then continue at an infusion of 1 mcg/kg/hour
干预措施: Dexmedetomidine sedation (Drug)
结局指标
主要结局
Mean obstruction score at the tongue base
时间窗: During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters
The degree of obstruction is scored on a 4-point scale as 0% (0), \<50% (1), 50-99% (2), or 100% (3). Scores from the 3 surgeons will be averaged for use in analysis.
次要结局
未报告次要终点
研究者
Erin Kirkham
Assistant Professor of Otolaryngology-Head and Neck Surgery
University of Michigan