Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- Diastolic Blood Pressure (DBP)
研究概览
简要总结
To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
- •ASA 1,2,3
- •females who have started menses but have a negative urine pregnancy test
排除标准
- •patients with known dysrhythmias,
- •not recovering in the ICU
- •developmental delay,
- •autism communication disorder
- •bleeding disorder
- •PI discretion
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
placebo
Normal saline
干预措施: Placebo (Other)
结局指标
主要结局
Diastolic Blood Pressure (DBP)
时间窗: Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.
Systolic Blood Pressure (SBP)
时间窗: Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.
Heart Rate (HR)
时间窗: Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
beats per minute (bpm)
次要结局
- Incidence of Emergence Agitation (EA)(The highest PAED score for each patient within the first 30 minutes after waking up was recorded.)
研究者
Peter Davis
Anesthesiologist-in-Chief
University of Pittsburgh