NCT05015361已完成2 期
Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation -- a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Phase II Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The time to maintain target sedation as a percentage of the total study administration time.
研究概览
简要总结
To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted 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 local anesthesia assisted sedation
- •Male or female
- •Meet the weight standard
- •Conform to the ASA Physical Status Classification
排除标准
- •Previous respiratory or pulmonary diseases
- •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
- •Abnormal values in the laboratory
- •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
Treatment group A/B
Experimental
Treatment group A: Remimazolam Tosilate Treatment group B: Remimazolam Tosilate
干预措施: Remimazolam Tosilate (Drug)
Treatment group C
Active Comparator
Treatment group C: Propofol Injection.
干预措施: Propofol Injection. (Drug)
结局指标
主要结局
The time to maintain target sedation as a percentage of the total study administration time.
时间窗: through study completion,an average of about 1 hour
次要结局
- The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation;(Time to achieve target sedation, an average of about 4 minutes)
- The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation(Recovery time, an average of about 7 minutes)
- Evaluation of subjects' satisfaction with sedation treatment;(through study completion,an average of about 1 hour)
- Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs;(3 minutes after administration)
- Anesthesiologists' satisfaction with sedation(through study completion,an average of about 1 hour)
- Incidence of anterograde amnesia.(through study completion,an average of about 1 hour)
- Proportion of subjects receiving remedial sedation;(through study completion,an average of about 1 hour)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of Remimazolam Tosilate for Prolonged Sedation in the ICUSedation in the ICUNCT05913336Jiangsu HengRui Medicine Co., Ltd.24
已完成
2 期
A Study of Remimazolam Tosilate for Sedation in the ICUSedation in the ICUNCT05152303Fujian Shengdi Pharmaceutical Co., Ltd.60
已完成
4 期
Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in AdultsHypotension During SurgeryNCT04908553Tongji Hospital650
已完成
3 期
A Study of Remimazolam Tosilate for Sedation in the ICUSedation in the ICUNCT06222294Jiangsu HengRui Medicine Co., Ltd.214
尚未招募
4 期
A Study of Remimazolam Tosilate for Sedation in Non-intubated Diagnostic and Therapeutic ProceduresSedation in Non-intubated Diagnostic and Therapeutic ProceduresNCT06216444Jiangsu HengRui Medicine Co., Ltd.240