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临床试验/NCT03466632
NCT03466632Unknown3 期

Randomised Study Comparing the Use of Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Tanta University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
100
试验地点
1
主要终点
Number of patients with adequate sedation

研究概览

简要总结

Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

详细描述

Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

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
Double (Participant, Care Provider)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 25-45 years,
  • ASA class I or II,
  • who are scheduled for elective outpatient colonoscopy

排除标准

  • refused to give informed consent
  • if they had known hypersensitivity to the used drugs
  • patients with morbidly obese patients
  • patients with increased risk for airway obstruction as obstructive sleep apnea,
  • Liver diseases

研究组 & 干预措施

• Propofol Group

Active Comparator

propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure..

干预措施: Propofol (Drug)

• Dexmedetomidine Group

Active Comparator

dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Number of patients with adequate sedation

时间窗: 6 months

the number of patients adequately sedated

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherief Abd-Elsalam

Principle investigator

Tanta University

研究点 (1)

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