A Comparison of S-ketamin, Dexmedetomidine, and Combination as Premedication in Children Undergoing ENT Surgery
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
- 否
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
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
0.3 μg/kg intravenous injection s-ketamin
干预措施: S-ketamine 0.3 (Drug)
0.5 SK iv
0.5 μg/kg intravenous injection s-ketamin
干预措施: S-ketamine 0.5 (Drug)
2 SK in
2 μg/kg intranasal s-ketamin
干预措施: S-ketamine 2 (Drug)
0.5 SK in + 2 DEX in
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
Hui Qiao
Clinical Anesthesiologist
Eye & ENT Hospital of Fudan University
