Evaluation of the Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization at Vietnam National Children's Hospital
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
- The rate of achieving Ramsay Sedation Scale score 6 without the need for rescue anesthesia and the occurrence of any adverse events throughout the duration of the cardiac catheterization procedure.
研究概览
简要总结
The goal of this observational study is to learn if the spontaneous sedation regimen of dexmedetomidine-ketamine (KETADEX) has the comparable efficacy and safety in pediatric cardiac catheterization versus the traditional regimen. The main question it aims to answer is:
Is the combined Dexmedetomidine-Ketamine spontaneous sedation regimen (KETADEX) non-inferior to the traditional general anesthesia regimen in terms of efficacy and safety?
Participants would received either KETADEX regimen or general anesthesia regimen. Research members then observe the catheterization procedure and answer the questionnaire about their efficacy and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under 18 years of age.
- •Patients indicated for diagnostic or interventional cardiac catheterization.
排除标准
- •Patients with acute respiratory infections, chromosomal abnormalities, metabolic disorders, or other co-existing medical conditions.
- •Arrhythmias, second- or third-degree atrioventricular (AV) block; patients on mechanical ventilation or requiring vasopressors prior to the procedure.
- •Known history of allergy or hypersensitivity to dexmedetomidine, ketamine, propofol, midazolam, or sevoflurane.
研究组 & 干预措施
KETADEX
Pediatric patients undergoing the dexmedetomidine-ketamine spontaneous sedation regimen on cardiac catheterization
干预措施: Spontaneous sedation regimen (Drug)
GA
Pediatric patients undergoing the traditional general anesthesia regimen on cardiac catheterization
干预措施: General anesthesia regimen (Drug)
结局指标
主要结局
The rate of achieving Ramsay Sedation Scale score 6 without the need for rescue anesthesia and the occurrence of any adverse events throughout the duration of the cardiac catheterization procedure.
时间窗: Perioperative/periprocedural
The primary endpoint is the rate of achieving the sedation target, which is Ramsay Sedation Scale score of 6, without the need for rescue anesthesia and without any adverse events in cardiovascular, respiratory, or neurological systems occurred during the anesthesia/sedation induction, cardiac catheterization, and recovery periods.
次要结局
- Incidence of respiratory adverse events throughout the duration of the cardiac catheterization procedure(Perioperative/periprocedural)
- Incidence of cardiovascular adverse events throughout the duration of the cardiac catheterization procedure(Perioperative/periprocedural)
- Incidence of neurological adverse events throughout the recovery period.(Up to 3 hours post-procedural)
- Incidence of any of the adverse events during the use of the sedation and anesthesia regimen(From sedation initiation to the end of the procedure)
- Incidence of any of the adverse events during the recovery from the procedure(Up to 3 hours post-procedural)
研究者
Nguyen Thi Hong Ha
Head of Pharmacy Department
National Children's Hospital, Vietnam