An Open-Label Study to Evaluate the Efficacy and Safety of JNJ-268229 in Pediatric Subjects General Anesthetised
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Number of participants with positive response to skin incision
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during maintenance of general anesthesia.
详细描述
This is multicenter, open-label (identity of assigned study drug will be known) one-arm study in pediatric participants receiving general anesthesia. The participants are children aged 1-15 years old, planned to undergo head and neck, thoracic (except heart), urological, orthopedic or plastic surgery. Approximately 80 participants will be enrolled in this study. These participants are divided into two groups by age (1-6 and 7-15 years old). Pharmacokinetic (what the body does to the drug,) blood samples will be collected from at least 3 participants between the ages of 1 and 6 years and at least 3 participants between the ages of 7 and 15 years from 15 minutes after the start of infusion to the end of infusion of the study drug . The study consists of 4 phases: screening phase, treatment phase, recovery phase and follow-up phase. Screening for eligible participants will be performed within 14 days before administration of the study drug. The safety and tolerability of study drug will be evaluated by physical examinations, electrocardiogram (ECG), clinical laboratory tests, vital signs, and adverse events (AEs) according to the Time and Events Schedule. Participants safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants scheduled to receive surgery under general anesthesia, necessitating airway securing with tracheal intubation and analgesia with opioid analgesics
- •American Society of Anesthesiologists (ASA) Physical Status Classification is I or II at the time of operation planning
- •Participants scheduled to receive operations estimated to take 30 minutes or more from skin incision i.e. Head and neck, thoracic (except heart), intraperitoneal, ophthalmological, otorhinolaryngological, urological, orthopedic or plastic surgery
- •Girls having undergone menarche are eligible only if the urine pregnancy test at the time of screening is negative
排除标准
- •Chronic use of opioid analgesics or their use within 12 hours before the planned start of general anesthesia - Hypersensitivity to opioid analgesics or local anesthetics
- •History of jaundice or unexplained fever induced by halogenated anesthetics
- •Unstable hemodynamics (eg. congenital heart disease, congenital diaphragmatic hernia) Ideal body weight is not within the 10th to 90th percentile received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned first dose of study drug or is currently enrolled in an investigational study
研究组 & 干预措施
Remifentanil (0.25 µg/kg/min)
干预措施: Remifentanil (Drug)
结局指标
主要结局
Number of participants with positive response to skin incision
时间窗: 5-minute assessment period after skin incision
Positive response is defined by the presence of at least one of below listed conditions: Heart rate increased \>20% above baseline (that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision) for \>1 minute); Systolic blood pressure increased \>20% above baseline (that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision) for \>1 minute; Gross movement, swallowing, eye opening (if there are patches on the eyes, this assessment might be not evaluated) or grimacing and sweating, lachrymation or mydriasis.
次要结局
- Hemodynamics stability(5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure)
- Time from completion of anesthesia to resumption of spontaneous respiration(1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure)
- Time until arrival of Steward Postanesthetic Recovery Score at 6(240 minutes after completion of anesthesia or skin closure)
- Drugs used to deal with insufficient anesthesia (inadequate anesthesia) or excessive anesthesia(Time interval between completion of anesthesia and extubation)
- Assessment on analgesic effect(240 minutes after completion of anesthesia)
- Total dose level of remifentanil(1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure)
- Total concomitant anesthetic dose level(1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure)
- Time from completion of anesthesia to discharge from the recovery room(240 minutes after completion of anesthesia or skin closure)
- Respiratory stability(5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure)