Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Adults
试验速览
- 阶段
- 2 期
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults. To explore the reasonable dosage of dexmedetomidine hydrochloride nasal spray for preoperative sedation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Subjects requiring elective general anesthesia surgery
- •Male or female
- •Meet the weight standard
- •Conform to the ASA Physical Status Classification
排除标准
- •Not suitable for nasal spray
- •Subjects who had received general anesthesia
- •Subjects with a history of myocardial infarction or unstable angina pectoris
- •Subjects with atrioventricular block or cardiac insufficiency
- •Subjects with a history of ischemic stroke or transient ischemic attack
- •Subjects with poor blood pressure control after medication
- •Subjects with abnormal clotting function
- •Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- •Subjects with a history or possibility of a difficult airway
- •Subject with a history of substance abuse and drug abuse
- •Adrenoceptor agonists or antagonists were used before randomization
- •Abnormal values in the laboratory
- •Thyroid dysfunction
- •Allergic to a drug ingredient or component
- •Pregnant or nursing women
- •No birth control during the specified period of time
- •Participated in clinical trials of other drugs (received experimental drugs)
- •The inestigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
High dose group
In the low dose group, 36 subjects will receive a low dose of dexmedetomidine nasal spray.
干预措施: dexmedetomidine nasal spray (Drug)
Low dose group
In the high dose group, 36 subjects will receive a high dose of dexmedetomidine nasal spray.
干预措施: dexmedetomidine nasal spray (Drug)
Placebo group
In the placebo group，36 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
干预措施: dexmedetomidine hydrochloride nasal spray blank preparation (Drug)
结局指标
主要结局
Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes
时间窗: 0 minute to 45 minutes after administration
Evaluated with Ramsay sedation scale Score Response 1. Anxious or restless or both 2. Cooperative, orientated and tranquil 3. Responding to commands 4. Brisk response to stimulus 5. Sluggish response to stimulus 6. No response to stimulus
次要结局
- Total consumption of propofol during bispectral index reaches 60 for the first time(The bispectral index reaches 60 for the first time during intraoperative)
- Total consumption of opioid analgesic during bispectral index reaches 60 for the first time(The bispectral index reaches 60 for the first time during intraoperative)
- Subjects' satisfaction rating(From the end of surgical operation up to 24 hours)
- Total consumption of propofol during general anesthesia(From the beginning of anesthesia to the end of surgical operation up to 4 hours)
- The BIS value for the Ramsay sedation score of 3 for the first time after administration(The Ramsay sedation score of 3 for the first time during intraoperative)
- Total consumption of opioid analgesic during general anesthesia(From the beginning of anesthesia to the end of surgical operation up to 4 hours)
- Anesthesiologist satisfaction rating(At the end of surgery when the patient recovers from anesthesia)