NCT06203431招募中3 期
A Multicenter, Randomized, Double-blind, Etomidate-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of ET-26 for Induction of General Anesthesia in Subjects Undergoing Elective Surgery
Ahon Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2023年10月11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
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Success rate of anesthesia induction
研究概览
简要总结
This is a multicenter, randomized, double-blind, etomidate-controlled phase III clinical trial. The primary objective is to compare the efficacy and safety between ET-26 and etomidate in the induction of general anesthesia in subjects undergoing elective surgery, so as to provide a reference for the marketing registration of methoetomidate hydrochloride for injection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Inpatients requiring tracheal intubation under general anesthesia for Non-emergency, non-cardiothoracic, non-extracranial elective surgery estimated operation duration ≥ 0.5h;
- •Age ≥ 18 and ≤ 70 years old, gender is not limited;
- •ASA（American Society of Anesthesiologists） Class I-II;
- •Body mass index (BMI) 18 ~ 30 kg/m2 (including boundary value);
- •Serum cortisol concentration test is normal or abnormal but judged no clinical significance by the investigator;
- •Vital signs during screening: respiratory rate≥ 10 and ≤ 24 breaths /minute; When breathing air, pulse oxygen saturation (SpO2)≥95%; Systolic blood pressure (SBP) ≥ 90mmHg and ≤160mmHg; diastolic blood pressure (DBP) ≥ 60mmHg and ≤100mmHg; heart rate (ECG results) ≥ 55 and ≤ 100 beats/min;
- •Subjects must understand the procedures and methods of this study and be willing to sign informed consent and strictly abide by this trial protocol to complete the study.
排除标准
- •Subjects with contraindications to general anesthesia or previous history of anesthesia accidents, and other systemic medical history that increases the risk of anesthesia;
- •Known or suspected family history of malignant hyperthermia;
- •Known or suspected of being allergic or contraindicated to the procedural medication prescribed in each component or regimen of the experimental drug, suspected of epilepsy or severe liver and kidney dysfunction;
- •Difficulty in intubation or ventilation is expected (Modified Mallampati Score of Ⅲ and Ⅳ);
- •Presence of any of the following respiratory management risks before/at screening: 1) history of asthma, stridor; 2) Patients with sleep apnea syndrome;
- •Any of the following drugs or treatments were used prior to screening: 1) those who participated in any drug clinical trial within 1 month prior to screening; 2) Have used drugs or treatments that affect cortical function within 3 days before screening; 3) Use of drugs that may affect the QT interval within 2 weeks prior to screening;
- •The laboratory examination indicators during the screening period meet the following standards:
- •AST and /or ALT ≥ 3×ULN; 2)TBIL≥1.5×ULN； 3) Hb≤90 g/L (and no blood transfusion within 14 days); 4)ANC≤1.5×109/L； 5)PLT≤80×109/L； 6) Blood Serum creatinine ≥1.5×ULN;
- •Pregnant and lactating women; the reluctance of fertile women or men to use contraception throughout the trial; subjects (including male subjects) who had pregnancy plans within three months of the trial;
- •Subjects who have any other factors deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
Drug ET-26
Experimental
干预措施: ET-26 (Drug)
Drug Etomidate
Active Comparator
干预措施: Etomidate Injectable Emulsion (Drug)
结局指标
主要结局
Success rate of anesthesia induction
时间窗: within 7minutes after injection
modified observer's assessment of alert≤1 (only one additional dose was allowed) and endotracheal intubation was completed within 7 minutes from the beginning of study drug infusion, and no remedial drugs were used
次要结局
- The percentage of subjects with eyelash reflexes disappearing(within 3 minutes after injection)
- The time to successfully intubate(within 7minutes after injection)
- intubation reaction(within 5 minutes after successful intubation)
- The percentage of time between 40≤BIS（Bispectral index）≤60(During the period from the initial administration to the successful intubation of the tracheal tube,every 1 minute±20 seconds, within 7minutes after injection)
- time required to achieve eyelash reflex disappearance(within 3 minutes after injection)
- the use of investigational drugs and remedial drugs(Induction period of anesthesia,within 7minutes after injection)
- Proportion of subjects using remedial sedatives(Induction period of anesthesia,within 7minutes after injection)
- Time to loss of consciousness(Time from first administration of study drug to MOAA/S（modified observer's assessment of alert）≤1,every 1 minute ±5 seconds, within 3 minutes after injection)
- Changes of BIS（Bispectral index） within 30 minutes after endotracheal intubation successfully (such as the time percentage between BIS 40 and BIS 60)(30 minutes after successful intubation)
- Anesthesiologists' satisfaction scores on the transition between induction and maintenance of anesthesia.(immediately after surgery)
研究者
研究点 (1)
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