Safety and Dose Exploration of Remimazolam Tosilate for Injection for Induction and Maintenance of General Anesthesia Intubation for Elective Short-term Surgery in Adults: a Multi-center, Randomized, Double-blind Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Incidence of hypotension during the anesthesia
研究概览
简要总结
Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for Injection for induction and maintenance of general anesthesia in elective short-term surgery in adults.
Main research indicators:(1)Success rate of sedation during induction and maintenance of general anesthesia with remazolam tosylate;(2)The incidence and severity of hypotension in the induction and maintenance phases Study design: Multi-center, randomized, double-blind clinical study. Subject population: patients undergoing elective short-term surgery. Research data collection period: The subject signs the consent form until discharge or death in the hospital or withdrawal from the research.
Number of research centers/sample size: It is planned to enroll 600 patients from 11 hospitals.
Research process: The researchers will include patients who meet the enrollment criteria and agree to participate in the investigation of the support laryngoscope surgery and minor head and neck surgery patients from the elective surgery patients.
详细描述
The data collected in this study is recorded by the researcher in the eCRF, including:
- Data to be collected during the screening period and before the operation: the basic characteristics of the patient and demographic data;
- Data to be recorded during and/or postoperatively: main research indicators, secondary indicators and other indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •ASA Ⅰ-Ⅲ grade;
- •age 18-65 years old;
- •gender is not limited;
- •planned elective support laryngoscope surgery (glottic polypectomy under support laryngoscope, epiglottic cyst excision under support laryngoscope, benign laryngeal under support laryngoscope Lesion resection), endoscopic septoplasty, endoscopic tympanoplasty, endoscopic middle ear tube insertion, nasopharyngoplasty, head and neck benign mass resection for general anesthesia intubation patients;
- •operation time No more than 90min.
排除标准
- •Emergency surgery;
- •abnormal renal function (urea nitrogen ≥1.5×ULN, blood creatinine greater than the upper limit of normal);
- •abnormal liver function;
- •hypovolemia, shock or coma;
- •suffering from mental illness and long-term use of psychotropic drugs;
- •cognition Dysfunction;
- •those who are allergic to or contraindicated to benzodiazepines and their drug components; pregnant or lactating female patients;
- •have a history of drug dependence;
- •have used other sedatives in the past week;
- •have been a subject within the past 3 months Participated in drug clinical trials
研究组 & 干预措施
low dose group
Remimazolam Tosilate for Injection 0.1mg/kg at induction
干预措施: Remimazolam Tosilate for Injection 0.1mg/kg (Drug)
medium dose group
Remimazolam Tosilate for Injection 0.15mg/kg at induction
干预措施: Remimazolam Tosilate for Injection 0.15mg/kg (Drug)
high dose group
Remimazolam Tosilate for Injection 0.2mg/kg at induction
干预措施: Remimazolam Tosilate for Injection 0.2mg/kg (Drug)
结局指标
主要结局
Incidence of hypotension during the anesthesia
时间窗: during the anesthesia procedure
The systolic blood pressure during the anesthesia is ≤ 90 mmHg, or a reduction of \>20% from the baseline period, or the average blood pressure is \<65 mmHg
The rate of Successful sedation during the anesthesia
时间窗: during the anesthesia procedure
Successful sedation during the anesthesia is defined as: 1) successful induction of anesthesia without anesthesia remedial measures during the induction period; 2) no recovery during the anesthesia maintenance period, no unexpected physical activity, and no remedial measures during the maintenance period anesthesia.
次要结局
未报告次要终点
研究者
Ailin Luo
Principal Investigator, professor
Tongji Hospital