A Comparative Study of the Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sedation success rate
研究概览
简要总结
By comparing the application effects of three drugs in pediatric preoperative sedation, this study explores the optimal medication regimen, aiming to provide safer, more effective, and more personalized medication options for pediatric preoperative sedation. Additionally, this research will also focus on the impact of these three drugs on postoperative agitation in children, offering valuable references for the overall management of pediatric surgical anesthesia.
详细描述
Participants will be randomly allocated to three groups: remimazolam group(Group A), dexmedetomidine group(Group B), esketamine group(Group C). Before entering the operating room, an intravenous access is established. Under the accompaniment of a parent, one of the three drugs is administered intravenously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 2 to 5 years old
- •the American Society of Anesthesiologists (ASA) physical status of Class I
- •scheduled for adenotonsillectomy under general anesthesia, will be included.
排除标准
- •Abnormal lung function and respiratory system function
- •airway obstruction or deformity, history of mental illness
- •electrocardiogram indicating bradycardia
- •history of cardiac disease
研究组 & 干预措施
Remimazolam group: Remimazolam is administered intravenously at a dose of 0.3 mg/kg
Remimazolam is administered intravenously at a dose of 0.3 mg/kg
干预措施: remimazolam group (Drug)
dexmedetomidine group: dexmedetomidine is administered intravenously at a dose of 1 μg/kg
dexmedetomidine is administered intravenously at a dose of 1 μg/kg
干预措施: dexmedetomidine group (Drug)
esketamine group: esketamine is administered intravenously at a dose of 0.5 mg/kg
esketamine is administered intravenously at a dose of 0.5 mg/kg
干预措施: esketamine group (Drug)
结局指标
主要结局
Sedation success rate
时间窗: 0, 3, 5, 10 minutes after the drug injection
1 points represents the child being restless and irritable; 2 points represents that the child is quiet and cooperative; 3 points represents that the child is drowsy and able to obey instructions; A score of 4 indicates that the child is in a shallow sleep state and can be quickly awakened; 5 points represent the child falling asleep and having a slow response to calls; 6 points represent the child's deep sleep state and no response to calls. If the Ramasay score greater than 2 points, it is considered a successful sedation.
Onset time of sedation
时间窗: 0, 3, 5, 10 minutes after the drug injection
The time from the end of drug injection until the Ramsay score is greater than 2 points. If the Ramasay score greater than 2 points, it is considered a successful sedation. 1 points of ramasay scorere presents the child being restless and irritable; 2 points represents that the child is quiet and cooperative; 3 points represents that the child is drowsy and able to obey instructions; A score of 4 indicates that the child is in a shallow sleep state and can be quickly awakened; 5 points represent the child falling asleep and having a slow response to calls; 6 points represent the child's deep sleep state and no response to calls.
Parent-Child Separation Anxiety Score (PASA Score)
时间窗: 0, 3, 5, 10 minute after the drug injection
if the PASA score is greater than 2, it is considered a positive reaction to separation anxiety. 1 point represents that the child is easily separated from their parents；A score of 2 indicates that the child has crying sounds, easily comforted, and does not rely on their parents；A score of 3 indicates that the child is crying and cannot be comforted, but does not rely on their parents；4 points represent the child crying and relying on their parents
次要结局
- incidence of adverse reactions(during intravenous bolus administration of sedative drugs and anesthesia induction)
- Mask Acceptance Score (MAS)(0, 3, 5, 10 minutes after the drug injection)
- blood pressure(0,3,5,10 minute after drug injectuion)
- restlessness rating scale for awakening period(PAED)(0, 5, 10, 20 minutes after the patient awake)
- respiratory rate(0,3,5,10 minute after drug injectuion)
- Heart rate(0, 3, 5, and 10 minutes after the drug injection)
- pulse oximetry saturation(0,3,5,10 minute after drug injectuion)
研究者
Li Na
Deputy Chief Physician
Maternal and Child Health Hospital of Hubei Province