NCT03698617已完成2 期
A Phase IIa, Open-label, Propofol-controlled ,Dose-escalation, Multi-center Study to Evaluate the Tolerance, Efficacy and Safety of HSK3486 for Induction of General Anesthesia in Elective Surgery Patients.
Sichuan Haisco Pharmaceutical Group Co., Ltd1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2016年12月6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
- 114
- 试验地点
- 1
- 主要终点
- The success rate of induction of general anesthesia
研究概览
简要总结
This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Inpatients required tracheal intubation under general anesthesia and a non-emergency non-cardiothoracic and non-extracranial elective surgery for an estimated duration of ≤ 3 h ;.
- •Males or females, aged ≥ 18 and ≤ 65 years old;
- •Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2;
- •ASA grade I~II;
- •Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.
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
- •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 one month prior to the screening period.
- •Patients in receipt of general anesthesia surgery within two weeks prior to the screening period.
- •The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, liver, kidney, blood system, or metabolic system disease prior to the screening period.
- •Abnormal laboratory results consisting of any of the following: :
- •AST and ALT≥ 2×ULN； 2）TBIL≥ 1.5×ULN； 3）Hb≤ 90g/L; 4）ANC≤1.5×109/L; 5) PLT≤80×109/L； 6） serum creatinine≥ 1.5×ULN.
- •Patients with a history of drug or ethanol abuse with the past 3 months.
- •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 a positive Allen 's test who collected arterial blood for PK study.
- •Patients with respiratory management difficulties.
- •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
Dose Escalation Cohort:
0.1 mg/kg, 0.2 mg/kg, 0.3mg/kg 0.4 mg/kg 0.5 mg/kg, 0.6 mg/kg, 0.7mg/kg, 0.8 mg/kg Dose Expansion Cohort: 0.3 mg/kg and 0.5 mg/kg.
干预措施: HSK3486 (Drug)
Propofol
Active Comparator
Dose Escalation Cohorts:2.0mg/kg and 2.5mg/kg; Dose Expansion Cohorts: 2.0mg/kg
干预措施: Propofol (Drug)
结局指标
主要结局
The success rate of induction of general anesthesia
时间窗: during induction of general anesthesia on day 1
To find the MTD or the RP2D of HSK3486 in the induction of general anesthesia, the success rate of induction of general anesthesia is the primary outcome measurement.
次要结局
- Time from start of IMP administration to loss of eyelash reflex(during induction of general anesthesia on day 1)
- change from baseline in blood pressure （systolic, diastolic and mean arterial pressure)(pre-dose to 20 minutes post-dose)
- change from baseline in arterial oxygen saturation(pre-dose to 20 minutes post-dose)
- Time from start of IMP administration to intubation and the intubation reaction(during induction of general anesthesia on day 1)
- Number of patients with adverse events(Pre-dose to 48 hours post-dose)
- Time from start of IMP administration to loss of consciousness(during induction of general anesthesia on day 1)
- Mini-Mental State Examination (MMSE) total scores(0-30) by time point(Pre-dose to 48 hours post-dose)
- change from baseline in heart rate(pre-dose to 20 minutes post-dose)
研究者
研究点 (1)
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