The Effect of Low Dose of Midazolam on Blood Pressure and Anxiety Scale in White-coat Hypertensive Dental Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
Intravenous sedation was used for dealing with transient hypertension, so-called white-coat hypertension, before dental treatment. Midazolam used as a sedative also has antianxiety effect, and the mechanism is guessed that it minimizes patients' stress, resulting in the stability of blood pressure. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of low dose of midazolam on blood pressure and anxiety scale in white-coat hypertensive dental patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SBP>=140mmHg or DBP>=90mmHg measuring when the patient sits on dental chair and has settled down for 5 minutes among dental outpatients scheduling intravenous sedation with American Society of Anesthesiologists physical status I or II.
排除标准
- •Uncontrolled or unstable hypertension
- •Secondary hypertension such as hyperthyroidism and pheochromocytoma
- •Taking sympathomimetic drugs
- •Contraindication of midazolam such as myasthenia gravis and acute narrow-angle glaucoma
- •A pregnant woman or during lactation period
- •Psychiatric disorder such as schizophrenia
- •Not having intelligence enough to read, understand and write a Japanese version of STAI
- •Judged unsuitable by a researcher
研究组 & 干预措施
Midazolam
Intravenous administration of midazolam at dose of 0.02mg/kg
干预措施: Midazolam (Drug)
NSS
Intravenous administration of saline solution at dose of 0.004ml/kg as a placebo drug
干预措施: Normal Saline Solution (NSS) (Drug)
结局指标
主要结局
Blood pressure
时间窗: Until 10 minutes after drug administration
Heart rate
时间窗: Until 10 minutes after drug administration
Oxygen saturation
时间窗: Until 10 minutes after drug administration
次要结局
- Visual analog scale about anxiety to dental treatment(10 minutes after drug administration)
- Sedation level(10 minutes after drug administration)
- Japanese version of STAI(10 minutes after drug administration)
研究者
Yoshihisa Watanabe
Department of Dental Anesthesiology and Special Care Dentistry,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama University