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临床试验/NCT04757675
NCT04757675已完成早期 1 期

A Comparison of S-ketamin, Dexmedetomidine, and Combination as Premedication in Children Undergoing ENT Surgery

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: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
320
试验地点
1
主要终点
The modified Yale Preoperative Anxiety Scale

研究概览

简要总结

We aim to investigate the effects of premedication (intranasal or intravenous administration) of s-ketamin, dexmedetomidine, and combination for premedication in children undergoing ENT surgery.

详细描述

Three hundred children aged between 2 and 12 years were randomly allocated to one of five groups: 0.3 μg/kg intravenous injection s-ketamin; 0.5 μg/kg intravenous injection s-ketamin; 2 μg/kg intranasal s-ketamin group; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine group; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine group.

The modified Yale Preoperative Anxiety Scale (m-YPAS) was used to assess preoperative anxiety at 1, 5, 10, 20, and 30min after premedication. 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 Anesthesia Emergence Delirium [PAED] scale) and POV was 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
Treatment
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

  • After obtaining the informed consent from their parents or proxies, the children aged 2 to 12 years, scheduled for elective ENT surgery, of American Society of Anesthesiologists (ASA) I or II were enrolled in this study.

排除标准

  • Congenital heart diseases, congenital dysplasia, obstructive sleep apnea syndrome, upper respiratory tract infection, body mass index (BMI) ≥25, allergy to S-ketamin or dexmedetomidine, and severe liver or kidney disease.

研究组 & 干预措施

1 SK in + 1 DEX in

Experimental

1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine

干预措施: S-ketamine 1+Dexmedetomidine 1 (Drug)

0.3 SK iv

Experimental

0.3 μg/kg intravenous injection s-ketamin

干预措施: S-ketamine 0.3 (Drug)

0.5 SK iv

Experimental

0.5 μg/kg intravenous injection s-ketamin

干预措施: S-ketamine 0.5 (Drug)

2 SK in

Experimental

2 μg/kg intranasal s-ketamin

干预措施: S-ketamine 2 (Drug)

0.5 SK in + 2 DEX in

Experimental

0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine

干预措施: S-ketamine 0.5 +Dexmedetomidine 2 (Drug)

结局指标

主要结局

The modified Yale Preoperative Anxiety Scale

时间窗: 30 min after premedication

A validated observational tool for assessing children's anxiety

次要结局

  • Parental Separation Anxiety Scale (PSAS)(30 min after premedication)
  • Emotional State Scale(15 min after premedication)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui Qiao

Clinical Anesthesiologist

Eye & ENT Hospital of Fudan University

研究点 (1)

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