NCT04958746已完成3 期
A Multi-Center, Randomized, Double-Blind, Propofol Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2021年7月26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
- 135
- 试验地点
- 1
- 主要终点
- Success rate of anesthesia
研究概览
简要总结
This study is a multi-center, randomized, double-blind, Propofol parallel-controlled phase III clinical study, with the primary objective of evaluating the efficacy of Ciprofol vs. Propofol for the induction of sedation/anesthesia in subjects undergoing gynecological outpatient surgeries and secondary objective of evaluating the safety of Ciprofol in subjects undergoing gynecological outpatient surgeries.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient needing gynecological outpatient surgery under general anesthesia without endotracheal intubation;
- •Female, aged between 18-65 (inclusive);
- •American Society of Anesthesiologists (ASA) Class I- II
- •Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
- •Vital signs during the screening period meet the following criteria:
- •Respiratory rate ≥ 10 and ≤ 24 breaths/min;
- •Pulse oxygen saturation (SpO2) ≥ 95% when inhaling;
- •Systolic blood pressure (SBP) ≥ 85 mmHg and ≤ 140 mmHg;
- •Diastolic blood pressure (DBP) ≥ 50 mmHg and ≤ 90 mmHg;
- •Heart rate ≥ 50 beats/min and ≤ 100 beats/min. (Note: For heart rate, the heart rate results of 12-ECG examination are used as the basis for judging whether the inclusion criteria are met.)
- •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 with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
- •Known sensitivity to Propofol Injection, Ciprofol Injection, the excipients in the investigational drugs (soybean oil, glycerin, triglyceride, egg lecithin, purified lecithin, sodium oleate, sodium hydroxide and disodium edetate), and opioids or any ingredient of opioids; contraindications to Propofol;
- •Patients with positive urine HCG or blood HCG (except abortion, dilatation and curettage, other outpatient surgeries for termination of pregnancy);
- •Patients having the following medical history or evidence prior to screening, which may increase sedation/anesthesia risk:
- •History of cardiovascular diseases: Uncontrolled hypertension or SBP > 140 mmHg and/or DBP > 90 mmHg despite antihypertensive treatment, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months prior to screening, history of tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF interval ≥ 450 ms (Fridericia's correction formula) during screening;
- •Respiratory system disorders: Respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months prior to screening, acute respiratory tract infection with any one of the obvious symptoms such as fever, wheezing, or productive cough within 1 week prior to screening;
- •History of neurological and mental disorders: history of craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysm, or cerebrovascular accident; history of schizophrenia, mania, chronic use of antipsychotics, cognitive impairment, etc.;
- •History of gastrointestinal diseases: history of gastrointestinal retention, active hemorrhage, gastroesophageal reflux or obstruction, etc. which may cause reflux and aspiration, as per the judgment of the investigator;
- •History of uncontrolled and clinically significant diseases in such as liver, kidney, blood system, nervous system, or metabolic system judged by the investigator to be unsuitable for this trial;
- •History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine);
- •History of drug abuse within 3 months prior to screening;
- •Serious infection, trauma, or major surgery within 4 weeks prior to screening.
- •Patients with the following airway management risks at screening:
- •Asthma history, and stridor;
- •Sleep apnea syndrome;
- •History or family history of malignant hyperthermia;
- •History of intubation failure;
- •Judged by the investigator to have difficult airway or judged as difficult tracheal intubation (modified Mallampati score III or IV).
- •Receiving any one of the following medications or treatments at screening:
- •Participated in other clinical trials of drugs within 1 month prior to screening;
- •Used Propofol, other general sedatives/anesthetics, and/or opioid analgesics or compounds containing opioid analgesics within 3 days prior to screening.
- •Patient whose laboratory parameters measured at screening meet any of the following criteria and are verified through reexamination:
- •Neutrophil count < 1.5 × 109/L;
- •Platelet count < 80 × 109/L;
- •Hemoglobin < 90 g/L;
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3.0 × upper limit of normal (ULN)
- •Total bilirubin > 2 × ULN;
- •Serum creatinine > 1.5 × ULN.
- •Breastfeeding females; women of child-bearing potential who are unwilling to use contraception during the trial; or subjects who are planning pregnancy within 1 month after completion of the trial.
- •Subject judged by the investigator to have any other factors unsuitable for participation in the study.
研究组 & 干预措施
Ciprofol
Experimental
Ciprofol group：0.4/0.2mg/kg
干预措施: Ciprofol (Drug)
Propofol
Placebo Comparator
Propofol group：2.0/1.0mg/kg
干预措施: Propofol (Drug)
结局指标
主要结局
Success rate of anesthesia
时间窗: Day 1
The proportion of subjects successfully anesthetized in all subjects of the group.
次要结局
- Time to full recovery:(Day 1)
- Time to successful sedation/anesthetic induction(Day 1)
- Sedation/anesthesia satisfaction, including satisfaction evaluation of subjects, anesthesiologists, and surgeons.(Day 1)
- Time to discharge(Day 1)
研究者
研究点 (1)
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