Effective Dose of Remimazolam for Loss of Consciousness in Children: A Prospective Dose Finding Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Loss of consciousness
研究概览
简要总结
This study aims to find effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years old. We will explore ED90 of remimazolam for loss of consciousness in 2 minutes after intravenous injection, via a up-and-down method with biased-coin design.
详细描述
We will administer remimazolam intravenously to the study participants. Remimazolam will be infused in 30 seconds to the participants, and we will wait for 2 minutes for the participants be sedated.
When a participant was not sedated in 2 minutes, dose of remimazolam in the next participant will be escalated by 0.05mg/kg. When a participant was sedated in 2 minutes, dose of remimazolam in the next participant will be decreased by 0.05mg/kg or maintained as same. The probability of decrement and maintenance will be 90% and 10% respectively. The dose of remimazolam in the first participant of the study will be 0.05mg/kg.
We will collect the results and obtain ED90 of remimazolam for loss of consciousness in children aged 2 to 8 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children scheduled to undergo general anesthesia or sedation
- •American Society of Anesthesiologist Physical Status of 1 or 2
排除标准
- •Presence of Upper respiratory tract infection or any pulmonary disease
- •Presence of subglottic stenosis, laryngomalacia, or tracheomalacia
- •History of hypersensitivity to benzodiazepines or propofol
- •History of hypersensitivity to beans or peanut
- •History of seizure
- •Presence of arrhythmia, tachycardia, or bradycardia
- •Presence of acute closed-angle glaucoma
- •Patients with unstable vital sign
- •Presence of sleep apnea
- •Presence of galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder
- •History of hypersensitivity to dextran 40
- •Refusal to enroll by one or more parents or legal guardian
- •Other conditions the researchers regarded as inappropriate to enroll
研究组 & 干预措施
Study group
Remimazolam administration and evaluation of sedative effect
干预措施: Remimazolam besylate (Drug)
结局指标
主要结局
Loss of consciousness
时间窗: From start of remimazolam administration to 2 minute after end of administration
Score 3 or more in the University of Michigan Sedation Scale in less than 2 minutes after administration of remimazolam besylate
次要结局
- UMSS (University of Michigan Sedation Scale)(From start of remimazolam administration to 2 minute after end of administration)
- Heart rate(From start of remimazolam administration to 2 minute after end of administration)
- Pulse oximetry(From start of remimazolam administration to 2 minute after end of administration)
- Noninvasive mean blood pressure(From start of remimazolam administration to 2 minute after end of administration)
- Anesthetic depth(From start of remimazolam administration to 2 minute after end of administration)
- Apnea(From start of remimazolam administration to 2 minute after end of administration)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital