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®).
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
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