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临床试验/NCT02952222
NCT02952222已完成4 期

The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy

Keira Mason1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2018年5月11日最近更新:
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
39
试验地点
1
主要终点
Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine.

研究概览

简要总结

The primary aim of this study is to compare the propofol requirements of children who receive propofol with that of children who receive dexmedetomidine prior to propofol, for sedation for upper and lower endoscopic procedures.

详细描述

Both propofol and dexmedetomidine may be used to achieve adequate sedation conditions. Propofol has been described to produce successful conditions for completion of the intended study in almost 99% of the patients. However, in a study that reviewed outcomes when using propofol for almost 50,000 pediatric procedures, propofol was associated with stridor, laryngospasm, airway obstruction, wheezing or central apnea at a rate of 1 in 65 sedations. The need for airway and ventilation interventions which include oral/nasal airway placement, positive pressure mask ventilation and tracheal intubation occurred at a rate of 1 in 70 sedations. Hemodynamic and respiratory fluctuations of a minimum of 30% fluctuations in heart rate, blood pressure or respiratory rate occurred at a rate of 1 in 165 sedations. Another recent study cited similar incidences of hemodynamic variability with propofol as well as inhalational anesthesia in the outpatient pediatric setting.

Until 2015, dexmedetomidine had been one of the standard drugs administered for sedation in children who require radiologic diagnostic imaging studies (MRI, CT and Nuclear Medicine) in the Department of Radiology at Boston Children's Hospital (BCH). Over 17,000 infants, children and developmentally compromised young adults had been sedated with dexmedetomidine in BCH without a cardiac or respiratory arrest, or a need to provide positive pressure assisted ventilation.

This study will determine if administration of dexmedetomidine with propofol administration will result in lower doses of the latter, which may mean safer outcomes in sedation for upper and lower endoscopic procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 7-18 years who are scheduled for upper or lower endoscopic procedures at Boston Children's Hospital and meets criteria to receive dexmedetomidine or propofol sedation for upper and lower endoscopic procedures
  • Provides written consent to participate in the research study
  • For females of childbearing age, pregnancy test is negative

排除标准

  • Do not meet established sedation criteria
  • Refuses administration of study medication prior to sedation
  • History of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
  • Current, repaired or risk of Moya-Moya disease
  • Recent stroke (cerebrovascular accident) within past 6 months
  • Uncontrolled hypertension
  • Concomitant use of opioids, beta antagonist, alpha 2 agonist or calcium channel blocker
  • Egg, soy or lecithin allergy
  • BMI greater than 30 or weight above 110th percentile
  • Refuses insertion of intravenous catheter while awake
  • Currently receiving pharmacologic agents for hypertension or cardiac disease
  • Currently receiving or has received digoxin within the past 3 months
  • Active, uncontrolled gastroesophageal reflux - an aspiration risk
  • Current (or within past 3 months) history of apnea requiring an apnea monitor
  • Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction)
  • Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
  • Active, current respiratory issues that are different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory syncytial virus)

研究组 & 干预措施

Propofol (Group P)

Active Comparator

Propofol only

干预措施: Propofol (Group P) (Drug)

Propofol with Dexmedetomidine (Group DP)

Active Comparator

Propofol with Dexmedetomidine

干预措施: Dexmedetomidine (Drug)

Propofol with Dexmedetomidine (Group DP)

Active Comparator

Propofol with Dexmedetomidine

干预措施: Propofol (Group DP) (Drug)

结局指标

主要结局

Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine.

时间窗: up to 3 hours

Compare the total propofol requirements (in mg/kg/min) of children who receive intravenous propofol with pre-treatment of dexmedetomidine with the propofol requirements in children who do not receive dexmedetomidine.

次要结局

  • Frequency of Adverse Events and the Need for Airway Interventions(1 day)
  • Time Required to Achieve Sedation(up to 30 minutes)
  • Time Required to Meet Discharge Criteria From Recovery Room(up to 4 hours)
  • Adverse Events(3 days)
  • Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool(up to 3 hours)
  • Emergence Delirium(up to 4 hours)
  • Time to BIS Score(up to 6 hours)
  • Duration of Sedation(up to 3 hours)

研究者

发起方
Keira Mason
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Keira Mason

MD

Boston Children's Hospital

研究点 (1)

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