NCT03709056已完成2 期
A Phase IIb, Randomized, Double-blind, Propofol-controlled, Multi-center Study Evaluating the Efficacy and Safety of HSK3486 for Sedation and Anesthesia in Patients Undergoing Diagnostic Colonoscopy.
Sichuan Haisco Pharmaceutical Group Co., Ltd8 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2017年12月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 8
- 主要终点
- Success of colonoscopy procedure
研究概览
简要总结
A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.
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 70 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;
- •Male or female patients, ASA grade I~III, aged ≥ 18 and≤ 70;
- •Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
- •the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥55and ≤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.
- •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 before screening.
- •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) 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 0.4/0.2mg/kg ，0.5mg/kg/0.15mg/kg
Experimental
干预措施: HSK3486 (Drug)
Propofol 2.0/1.0mg/kg group
Active Comparator
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 fully alert(from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1)
- The success rate of the colonoscopy procedure(from the first dose of the study drug to removal of colonoscope on day 1)
- Time to discharge(from the removal of colonoscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1)
- Application of study drug and alternative medication(during the colonoscopy procedure on day 1)
- Time to start of procedure(From first dose of study drug until insertion of colonoscope on day 1)
研究者
研究点 (8)
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