The Effect of Different Dose of Dexmedetomidine Combined With Hydromorphone in Children With Tonsillectomy and Adenoidectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- extubation time
研究概览
简要总结
Tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation and severe postoperative pain have been considered a very common complications. Dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic receptor of the brainstem nucleus, which can produce good sedative effects. Hydromorphone has a longer duration of action than fentanyl, and it also has a certain sedative effect. The combination of the two is more conducive to the management of postanesthetic agitation and pain. This study was to compare the effect of different doses of dexmedetomidine combined with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and adenoidectomy.
详细描述
The computer generates random numbers to allocate patients into different group. Trained research staff who are not involved in the study collect the data. The observer who only stayed in PACU was blinded to the allocation and responsible to record the data.
The primary measurement are pain scores, PAED scores, coughing was evaluated on a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm), and extubation time. The secondary measurements are the time to discharge from the post-anaesthesia care unit, and the number of postoperative desaturation.
A sample size of 57 was determined by analysis based on the assumption of the decline of extubation time from other similar study and α=0.05,β=0.2.
The continuous variables were presented as means ± SD and the categorical variables were expressed as frequency.
The outcome of interest is extubation time decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •experienced tonsillectomy and adenoidectomy
- •ASA physical status I-II
- •weight 12-30 kg
排除标准
- •respiratory disease
- •circulatory or nervous system disease
- •hepatic dysfunction
- •known adverse reactions to hydromophine and dexmedetomidine
研究组 & 干预措施
group A
Dexmedetomidine(0.5 μg／kg)/hydromophine-based general anesthesia
干预措施: Dexmedetomidine 0.5μg／kg (Drug)
group B
Dexmedetomidine(1μg／kg)/hydromophine-based general anesthesia
干预措施: Dexmedetomidine 1μg／kg (Drug)
结局指标
主要结局
extubation time
时间窗: duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins
the time of extubation after surgery
Agitation scores
时间窗: scores at the time point of 15 minutes after extubation
pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable. Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of \>12 is diagnosed to agitation.
coughing score
时间窗: scores at the time point of 15 minutes after extubation
a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm)
次要结局
未报告次要终点