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临床试验/NCT04266340
NCT04266340已完成不适用

Effects of Different Premedication on Preoperative Sedation and Postoperative Agitation in Children Undergoing Ophthalmic and Otorhinolaryngologic Operations

Eye & ENT Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2020年12月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
1
主要终点
Sedation

研究概览

简要总结

The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group.

Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthe-sia Emergence Delirium [PAED] scale) and POV were assessed in the postanesthetic care unit (PACU).Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU and patients' satisfaction degree were also assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, 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

入选标准

  • 未提供

排除标准

  • a recent history of upper respiratory tract infection, a known allergy to dexmedetomidine or midazolam, inability to understand the consent process or parental refusal.

研究组 & 干预措施

placebo

Placebo Comparator

no premedication

干预措施: Saline (Drug)

oralmidazolam

Experimental

0.5 mg/kg oral midazolam group

干预措施: midazolam (Drug)

intravenous midazolam

Experimental

0.05 mg/kg intravenous injection midazolam group

干预措施: midazolam (Drug)

dexmedetomidine

Experimental

2.5µg/kg intranasal dexmedetomidine group

干预措施: dexmedetomidine (Drug)

结局指标

主要结局

Sedation

时间窗: 30 minutes after premedication

1. Rarely awake, needs shaking or shouting to wake up 2. Asleep, eyes closed, wakes up when called softly or lightly touched 3. Sleepy but eyes open spontaneously 4. Awake 5. Agitated

Emotional state

时间窗: 0 minutes after facemask application

1. Calm 2. Apprehensive, not smiling, tentative behaviour, withdrawn 3. Crying 4. Thrashing, crying with movement of arms and legs, resisting

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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