Valeriana Officinalis L. for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Signs and symptoms of anxiety
研究概览
简要总结
The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg in single oral doses one hour preoperative as conscious sedation during the impacted lower third molar surgery.
详细描述
Evaluate the efficacy of Valeriana officinalis L. (Valerian) for control of anxiety during third molar surgery. Study design: A single oral dose of either valerian (100 mg) or placebo was randomly administered one hour before each surgical procedure to 20 volunteers between 17 and 31 years of age. Anxiety level was assessed through questionnaires, physiological parameters (blood pressure and heart rate) and the observation of signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, 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
- 否
入选标准
- •Indication for bilateral extraction of asymptomatic impacted mandibular third molars in similar positions based on the Pell & Gregory classification
排除标准
- •Use of any type of medication in the 15 days prior to the onset of the study; history of hypersensitivity to the drugs, substances or materials employed in the experiment; pregnancy or lactation
研究组 & 干预措施
Valeriana officinalis L (100mg)
100 mg of Valeriana officinalis L. (Valerian)
干预措施: 100 mg of Valeriana officinalis L (Drug)
Placebo (100 mg)
Placebo 100mg
干预措施: Placebo 100mg (Drug)
结局指标
主要结局
Signs and symptoms of anxiety
时间窗: 1 day (during dental appointment)
During each surgery, the researcher and surgeon observed the manifestation of signs and symptoms associated to anxiety (restlessness/agitation/nervous ticks, paleness, excessive perspiration, tingling sensation in hands, feet or lips, change in breathing rhythm or depth). In the presence of one or more of these signs and symptoms, the patient was classified as anxious. If there was no manifestation of anxiety, the patient was classified as calm or relaxed
assessment of the blood pressure
时间窗: 1 day (during dental appointment)
The assessment of the blood pressure was performed at three moments: baseline, post-medication and end of surgery.
Assesment of heart rate
时间窗: 1 day (during dental appointment)
The assessment of the heart rate was performed at three moments: baseline, post-medication and end of surgery.
次要结局
- Oxygen saturation(1 day (During dental appointment))
- Side effects of drugs(1 week)
研究者
Marcos Luciano Pimenta Pinheiro
Professor of Pharmacology and Therapeutics, Department of Basic Science, Biologic and Health Sciences Faculty, Federal University of Vales do Jequitinhonha e Mucuri - UFVJM, Diamantina, Minas Gerais, Brazil.
Federal University of the Valleys of Jequitinhonha and Mucuri