jRCT2031230657招募中不适用
Efficacy, safety, and pharmacokinetics of CNS7056 in Japanese pediatric patients undergoing general anesthesia (P-REMI trial)
未提供0 个研究点目标入组 120 人开始时间: 2024年7月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 主要终点
- Percentage of patients who achieved loss of consciousness after the administration of CNS7056 alone
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 0age over 至 18age old not（—）
- 性别
- All
入选标准
- •1, A modified gestational age of>=45 weeks and <18 years old at the time of obtaining informed consent from a surrogate
- •Patients whose trachea are intubated, and who are artificially ventilated
- •Patients scheduled to be hospitalized for at least 3 days from the day before surgery to the day after surgery
- •American Society of Anesthesiologists physical status I-III
- •Patients who have been fully informed about the clinical trial, and a legal guardian (a surrogate) of the patients provide informed consent. Patients who provide informed assent, if the patient is a junior high school student or older. If the patient is under junior high school age, written assent is obtained whenever possible.
排除标准
- •Pregnant, lactating girl, potential pregnant, or patients who cannot consent to contracept during the study period (from the time of obtaining consent to the end of all prescribed observations). For female patients of childbearing potential, a negative pregnancy urine test must be performed from the date of obtaining consent to prior to administration of the study drug
- •Patients scheduled to receive regional anesthesia (spinal anesthesia, epidural anesthesia, or peripheral nerve block) from the time of admission to the operating room until completion of tracheal intubation (excluding the use topical local anesthetic such as Emla cream to secure intravenous line for fluid infusion or blood sampling, and test dose of local anesthetic (<=3 mL) for epidural catheter placement
- •Patients scheduled to undergo neurosurgery (excluding spine and spinal cord surgery), hepatectomy, liver transplantation, or cardiac surgery (excluding catheter intervention)
- •Emergency surgery patient
- •Patients with a scheduled surgery time less than 1 hour
- •Patients with hypertension or hypotension requiring medical treatment
- •Obese (>=30% overweight) or emaciation (>20% underweight) classified using Weight-for-Height Charts
- •Patients who require respiratory management with tracheal intubation postoperatively, and patients expected to have delayed extubation
- •Patients who have received remimazolam within 1 month
- •Patients who are taking benzodiazepines regularly or have a history of tolerance to benzodiazepines
- •Patients with a history of hypersensitivity to benzodiazepines, remifentanil hydrochloride, fentanyl citrate, rocuronium bromide, sugammadex sodium, or flumazenil
- •Patients with a history of hypersensitivity to lactose and dextran
- •Patients with acute angle-closure glaucoma
- •Patients with myasthenia gravis or myasthenic syndrome
- •Patients in shock or coma
- •Patients with rate-responsive cardiac pacemakers
- •Patients whose electroencephalogram monitoring may be unavailable due to organic brain damage
- •Patients who are expected to excessive bleeding (e.g., >15% of circulating blood volume) during surgery
- •Patients with a history of severe allergy
- •Patients with drug dependence or with a history of drug dependence
- •Patients who receive another investigational drug within 120 days before the start of CNS7056 infusion
- •Patients who have been diagnosed with developmental delay or have communication difficulty excluding neonates, infants, toddlers, and preschoolers
- •Patients whom the investigator or subinvestigator determines to be inappropriate for inclusion in the clinical trial
结局指标
主要结局
Percentage of patients who achieved loss of consciousness after the administration of CNS7056 alone
[Anesthesia induction] Percentage of patients who achieved loss of consciousness after the administration of CNS7056 alone
Percentage of anesthetic efficacy that CNS7056 provides
[Anesthesia maintenance] Percentage of anesthetic efficacy that CNS7056 provides (1) no awareness and amnesia during general anesthesia, (2) no rescue administration of anesthetic during maintenance of anesthesia, and (3) intentional movement during anesthesia
次要结局
- Physical examination
- Electrocardiogram
- Plasma concentrations of CNS7056 and CNS7054
研究者
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