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临床试验/NCT03091894
NCT03091894已完成4 期

Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea: A Prospective Randomized Controlled Trial

Essam Fathi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年4月9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
50
试验地点
1
主要终点
success of sedation

研究概览

简要总结

This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.

详细描述

Propofol is a commonly used intravenous anesthetic drug used for procedural sedation. Dexmedetomidine is an alpha 2 adrenergic receptor agonist which has a sedative and analgesic effects.In the current study the success of the sedation during drug induced sleep endoscopy will be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • age more than 18 years
  • patients with obstructive sleep apnea
  • ASA 1and2

排除标准

  • patient refusal
  • age less than 18 years
  • morbid obesity
  • known or suspected allergy to the studied drugs

研究组 & 干预措施

propofol

Active Comparator

patients will receive only propofol intravenous infusion for sedation

干预措施: Propofol (Drug)

propofol-dex.

Active Comparator

patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation

干预措施: Propofol (Drug)

propofol-dex.

Active Comparator

patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

success of sedation

时间窗: the duration of the procedure under sedation is usually about 20 minutes

to complete the procedure with diagnosis of site and degree of obstruction

次要结局

  • time until sufficient sedation(about 5-10 minutes from start of sedation)

研究者

发起方
Essam Fathi
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Essam Fathi

assistent professor

Zagazig University

研究点 (1)

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