NCT06624592招募中3 期
Sevoflurane/Dexmedetomidine vs. Isoflurane and Their Effects on Pediatric Emergence Delirium
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of subjects with emergence delirium
研究概览
简要总结
The purpose of this study is to measure the incidences of pediatric emergence delirium between the group receiving Isoflurane and the group receiving Sevoflurane plus intravenous push dexmedetomidine.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 2-7 years.
- •Surgeries include ENT cases (i.e., tonsillectomy/adenoidectomy), ophthalmology cases (i.e., strabismus), and urology cases.
- •Can be outpatient or General Care inpatient procedures.
- •All cases must include an IV and an endotracheal tube (ETT).
排除标准
- •Severe developmental/cognitive delay (unable to make eye contact, nonverbal, or inability to interact with providers for PAED scale assessment requirements)
- •TIVA cases.
- •No PIV in place during the case, planned PICU admission postoperatively.
- •Previous history of severe emergence delirium documented by a provider (via interventions or explicitly stated).
研究组 & 干预措施
Isoflurane group
Active Comparator
干预措施: Isoflurane (Drug)
Sevoflurane group
Active Comparator
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Number of subjects with emergence delirium
时间窗: Within 1 hour after dropped off by anesthesiology team
Total number of subjects with a Pediatric Anesthesia Emergence Delirium (PAED) score of \> 10. The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable total score is 20.
次要结局
- Post Anesthesia Care Unit (PACU) length of stay(Post-procedural (0-4 hours after anesthesiology drop off))
研究者
Lindsay L. Warner
Principal Investigator
Mayo Clinic
研究点 (1)
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