NCT03674008已完成3 期
A Phase III,Randomized, Double-blind, Propofol-controlled, Parallel-design, Multi-center Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia in Patients Undergoing Colonoscopy and Gastroscopy
Sichuan Haisco Pharmaceutical Group Co., Ltd1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2018年10月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Success of colonoscopy procedure
研究概览
简要总结
This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy.
The study will enroll approximately 280 adults. The maximum study duration is anticipated to be up to nine months.
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
- 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
- •Scheduled to undergo a diagnostic or therapeutic colonoscopy or gastroscopy;
- •Male or female patients, ASA grade I~II, aged ≥ 18 and < 65;
- •Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
- •During screening and baseline, the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥60 and ≤100;
- •Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily.
排除标准
- •Patients were contraindicated in general anesthesia.
- •Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated.
- •The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period.
- •Patients with a history of drug or ethanol abuse with the past 3 months.
- •Patients with respiratory management difficulties (Modified Mallampati grade IV).
- •Patients in receipt of any investigational drug within 30 days before screening.
- •Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours prior to baseline.
- •Abnormal laboratory results consisting of any of the following:
- •neutrophil count≤ 1.5×109/L； 2）platelet≤ 80×109/L； 3）hemoglobin≤ 90 g/L; 4）aspartate aminotransferase≥ 1.5×ULN； 5）total bilirubin≥ 1.5×ULN； 6） serum creatinine≥ 1.2×ULN.
- •Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients.
- •Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).
研究组 & 干预措施
HSK3486
Experimental
0.4mg/kg/0.2 mg/kg
干预措施: HSK3486 (Drug)
Propofol
Active Comparator
1.5mg/kg/0.75mg/kg
干预措施: Propofol (Drug)
结局指标
主要结局
Success of colonoscopy procedure
时间窗: from the first dose of the study drug to removal of colonoscope on day 1
Measured by completion of colonoscopy, no requirement for an alternative sedative or anesthesia drug and no requirement for more than 5 doses of study drug within any 15 minute period.
次要结局
- Time to start of procedure(From first dose of study drug until insertion of colonoscope or gastroscope on day 1)
- Time to fully alert(from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1)
- Time to discharge(from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1)
- The success rate of the gastroscopy procedure(from the first dose of the study drug to removal of gastroscope on day 1)
- The success rate of the colonoscopy and gastroscopy procedure(from the first dose of the study drug to rem oval of colonoscope and gastroscope on day 1)
- Time to induction of sedation or anaesthesia(from the first dose of the study drug to the first MOAA/S scores≤1 on day 1)
- Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians(from time to fully alert, until time to discharge on day 1)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of General Anesthesia in Elective Surgery SubjectsInduction of AnesthesiaNCT03808844Sichuan Haisco Pharmaceutical Group Co., Ltd178
已完成
3 期
Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient SurgeriesGynecological Outpatient SurgeryNCT04958746Haisco Pharmaceutical Group Co., Ltd.135
已完成
3 期
Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective SurgeryAnesthesiaNCT04711837Haisco-USA Pharmaceuticals, Inc.255
已完成
3 期
A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Subjects Undergoing Fiberoptic BronchoscopySedation or AnesthesiaNCT04111159Sichuan Haisco Pharmaceutical Group Co., Ltd267
已完成
3 期
A Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical VentilationSedation in Intensive CareNCT04620031Haisco Pharmaceutical Group Co., Ltd.135