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临床试验/EUCTR2014-002243-17-ES
EUCTR2014-002243-17-ES进行中(未招募)1 期

Conscious sedation for procedures in Dental and Minor Maxillofacial Surgery Unit: optimization of the dexmedetomidine dose (Dexdor®).

Clínica Universidad de Navarra/Universidad de Navarra0 个研究点目标入组 124 人开始时间: 2014年6月9日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
124

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1.Ability to provide informed consent and express his desire to meet all protocol requirements during the study.
  • 2.The patient should be able to meet with all requirements of the clinical trial.
  • 3.Above 18 years of age.
  • 4.A pregnancy test will be performed to women between 18 years old and menopause in order to rule out pregnancy unknown.
  • 5.The patient requires sedation to carry out one of the Dental procedures and Maxillofacial Surgery Unit: Complex wisdom 4 tooth extraction, Dental implants with or without bone stimulation.
  • 6.Individuals ASA I (healthy patient) or II (patient with a process mild systemic without limitations in daily activities.)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 34
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 90

排除标准

  • 1.Dexmedetomidine hypersensitivity
  • 2.HR < 45bpm. Most individuals who participate in the study will be youth or individuals with hypertension controlled with drugs decrease HR <60 bpm without any symptoms. So if the individual with HR>45bpm does not shows sign of low cardiac output, he will be considered candidates for the study.
  • 3.Heart block grade 2-3 without pacemaker
  • 4.Mean blood pressure < 60mmHg.
  • 5.Severe stroke.
  • 6.Pregnancy and breastfeeding

研究者

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