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临床试验/NCT01895348
NCT01895348已完成4 期

A Comparison of Surgical Outcome Following Drug-induced Sleep Endoscopic Diagnosis Using Propofol or Dexmedetomidine for Sedation : A Prospective Randomized Trial

Yonsei University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年7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
入组人数
60
试验地点
1
主要终点
Desaturation rate

研究概览

简要总结

Obstructive sleep apnea is a common disease, associated with cardiovascular disease, cerebrovascular disease, and many other medical conditions. Therefore the precise diagnosis and treatment are important. With drug-induced sleep endoscopy (DISE), the three-dimensional evaluation of upper airway and airway obstruction could be possible. The problem of the DISE is that there is the difference between a sedative-induced sleep and normal sleep. Moreover there were no standard sedation protocol of DISE. Propofol has short half-life, about 3 minutes, so the patients could recover quickly from it. In recent years, using target controlled infusion(TCI) of propofol, the effective effect-site concentration for DISE could be reached easily with hemodynamic stability and minimal toxic effect. In a previous pilot study, the endoscopy for the diagnosis of sleep apnea could be done successfully with propofol TCI. However there were some desaturation events, although the EEG showed that the patient was not in deep sleep enough. Therefore we thought that not only further study of propofol for DISE but also the study of other drugs for DISE will be needed to overcome this limitation. Dexmedetomidine, the selective α2-adrenoreceptor agonist, has analgesic effect and almost no respiratory depression, therefore it could be a good alternative drug for DISE. The purpose of this study is designing the appropriate sedation protocol for DISE using propofol or dexmedetomidine, and enabling the safer and more accurate DISE.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA class 1, 2
  • Age ≥ 20 yrs
  • undergoing drug-induced endoscopy

排除标准

  • patient's reject
  • patients with hearing impairment or neurological deficits
  • patients taking medicine that can affect the central nervous system
  • History of adverse drug reactions
  • Glasgow coma scale ≤ 15
  • could not undergo the endoscopy
  • could undergo the endoscopy, but do not undergo UPPP

研究组 & 干预措施

propofol only

Active Comparator

干预措施: Propofol (Drug)

propofol-remifentanil

Active Comparator

干预措施: propofol-remifentanil (Drug)

dexmedetomidine-remifentanil

Active Comparator

干预措施: Dexmedetomidine-remifentanil (Drug)

结局指标

主要结局

Desaturation rate

时间窗: Baseline / 5 min after remifentanil TCI start / 5 min after propofol TCI start or 10 min after dexmedetomidine loading start / every 5 min until surgeon can do endoscopy successfully / immediately after endoscopy

SpO2 \< 90% (checked by pulse oximetry)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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