NCT07669012招募中1 期
a Comparive Study of Ketamine-Propofol Versus Dexmedetomidine-Propofol Sedation in Pediatric Patients Undergoing Cardiac Catheterization for Device Closure of Simple Left-to-right Shunts
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
研究概览
简要总结
This study aims To compare the safety and efficacy of ketamine-propofol versus dexmedetomidine-propofol sedation in pediatric patients undergoing cardiac catheterization for device closure of simple left-to-right shunts
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-12 years, male or female
- •Weight ≥ 10 kg
- •Scheduled for elective transcatheter device closure of a simple left-to-right shunt, including:
- •Secundum atrial septal defect (ASD) suitable for device closure
- •Small muscular ventricular septal defect (VSD) eligible for percutaneous device closure
- •Patent ductus arteriosus (PDA) closure
- •Procedure performed with transthoracic or transesophageal echocardiographic guidance according to the cardiology team's practice
- •ASA physical status II-III
- •Written informed consent obtained from a parent or legal guardian
排除标准
- •Cyanotic congenital heart disease
- •Complex congenital cardiac lesions
- •Risk of pulmonary hypertensive crisis
- •Requirement for general anesthesia and cuffed endotracheal tube at the discretion of the cardiology or anesthesia team
- •Baseline oxygen requirement > 2 L/min
- •Use of noninvasive ventilation
- •Known allergy or intolerance to ketamine, dexmedetomidine, or propofol
- •Significant hepatic impairment
- •Significant renal impairment
- •Advanced atrioventricular block
- •Clinically significant bradyarrhythmia
- •Uncontrolled epilepsy
- •Raised intracranial pressure
- •Severe obstructive sleep apnea
- •Craniofacial anomalies associated with anticipated difficult airway management
- •BMI > 97th percentile when judged to confer high risk of sedation-related airway obstruction
- •Current beta-blocker use
- •Current clonidine use
- •Acute upper respiratory tract infection within 2 weeks before the procedure
- •Emergency or add-on procedures
- •Anticipated procedure duration < 20 minutes
- •Anticipated procedure duration > 3 hours
研究者
研究点 (1)
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