A Multicenter, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of BT-KTM-I Versus Ketanest® S for General Anesthesia in Elective Laparoscopic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 358
- 试验地点
- 12
- 主要终点
- The awakening time from anesthesia
研究概览
简要总结
The objective is to evaluate the efficacy and safety of BT-KTM-I(Esketamine Hydrochloride Injection produced by Chengdu Brilliant Pharmaceutical Co., Ltd.) for general anesthesia, using the Originator drug Ketanest®S(Esketamine Hydrochloride Injection) as a positive control.
详细描述
This is a multicenter, randomized, double-blind, positive drug parallel controlled clinical trial, planned to include 358 subjects, including 179 in the experimental group and 179 in the control group. The entire study was divided into a screening period, surgery day, and follow-up observation period. The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h. The experiment used vital signs, physical examination, laboratory examination, 12-lead electrocardiogram examination, and adverse events/serious adverse events for safety evaluation.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18 to 60 years old (including threshold), regardless of gender;
- •Patients undergoing elective general anesthesia laparoscopic surgery (only tracheal intubation mechanical ventilation), 1 hour ≤ expected anesthesia time ≤ 2.5 hours;
- •The American Society of Anesthesiologists (ASA) score of Class I or II;
- •18kg/m2<BMI<30kg/m2;
- •The subjects understand the purpose and procedure of this experiment, voluntarily participate in this experiment, and sign a written informed consent form.
排除标准
- •Patients with contraindications to general anesthesia, or those who have had previous anesthesia accidents;
- •Known intolerance or allergy to ketamine hydrochloride, esketamine hydrochloride, propofol, rocuronium bromide, opioids, neostigmine, atropine, belladonnae alkaloids;
- •Long-term (continuous or intermittent) use of benzodiazepines sleeping pills, opioid analgesics, or use of narcotic analgesics within 24 hours before randomization or use of narcotic drugs within 7 days;
- •Have a history of increased intraocular pressure (such as glaucoma) or puncture eye injury;
- •Patients with a history of asthma;
- •Patients with mental system diseases (schizophrenia, mania, insanity, etc.) or cognitive disorders;
- •Patients with a history of craniocerebral injury, possible presence of intracranial hypertension, cerebral aneurysm, cerebrovascular accident, and central nervous system disease;
- •Have a serious history of cardiovascular diseases (such as myocardial ischemia, heart failure and severe arrhythmia); Angina pectoris (unstable angina) caused by insufficient blood supply to the coronary arteries of the heart, or myocardial infarction occurring within the first 6 months before screening;
- •Hypertensive patients with systolic blood pressure still ≥ 140mmHg and/or diastolic blood pressure still ≥ 90mmHg after treatment with antihypertensive drugs;
- •Diabetic patients whose blood glucose was not satisfactorily controlled (fasting blood glucose ≥11.1mmol/L during the screening period);
- •Severe lipid metabolism abnormalities (such as triglycerides>5mmol/L, diabetic hyperlipidemia, familial hypercholesterolemia, lipoid nephropathy, acute pancreatitis with hyperlipidemia, etc.);
- •Have a history of hyperthyroidism;
- •Have a history of drug use within 2 years before screening;
- •Individuals with a history of alcohol abuse within 2 years before screening. alcoholism is defined as drinking more than 14 units of alcohol per week (1 unit =360mL beer or 45mL spirits with 40% alcohol or 150mL wine) or acute alcoholism or alcohol dependence;
- •Participants in any clinical trial (defined as receiving the experimental drug or placebo) within 3 months prior to screening;
- •Patients with respiratory management difficulties as determined by the investigators (modified Markov score level Ⅳ);
- •Abnormal coagulation function (PT or PT-INR ≥ 1.5×ULN, APTT ≥ 1.5×ULN), or with bleeding tendency (such as active digestive ulcer) or undergoing thrombolytic or anticoagulant treatment;
- •Anemia or thrombocytopenia (PLT≤80×109/L, HGB≤90g/L);
- •Abnormal liver function [ALT and (or) AST≥1.5×ULN, TBIL≥1.5×ULN];
- •Abnormal renal function (BUN≥1.5×ULN; Cr≥1.2×ULN)
- •Pregnant or lactating women; Women or men with fertility are unwilling to use contraception between the screening period and the end of the trial;
- •Subjects who are deemed by the investigators to have any other unfavorable factors for participating in this clinical trial.
研究组 & 干预措施
BT-KTM-I
Patients received 0.5mg/kg BT-KTM-I during anesthesia induction period. Patients received 0.5mg/kg/h BT-KTM-I during anesthesia maintenance period.
干预措施: BT-KTM-I (Drug)
Ketanest®S
Patients received 0.5mg/kg Ketanest®S during anesthesia induction period. Patients received 0.5mg/kg/h Ketanest®S during anesthesia maintenance period.
干预措施: Ketanest®S (Drug)
结局指标
主要结局
The awakening time from anesthesia
时间窗: The time from discontinuing the use of anesthetics (propofol) to subjects waking up immediately after surgery (following instructions to open their eyes)
次要结局
- Incidence of adverse reactions in the mental system(Within 60 minutes after the subject wakes up)