Intranasal Dexmedetomidine or Oral Midazolam Alone Versus Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Minor Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- The degree of cooperation during inhalation anesthesia induction
研究概览
简要总结
Children tend to anxiety and even fear before survey. And this kind of anxiety will not result in the forced induction of anesthesia, but also may increase the incidence of postoperative agitation in children, even lead to postoperative behavior changes.Currently,Oral midazolam or intranasal dexmedetomidine alone is commonly used as a preoperative regimen, but the clinical effects of each single-use are not satisfactory. In the investigators' study，the researchers conducted the current study to investigate whether dexmedetomidine combined with midazolam can increase the rate of satisfactory anesthesia induction in pediatric patients and achieve better sedative effect.
详细描述
A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
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
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •with American Society of Anesthesiologists (ASA) physical status I or II；
- •aged 2-6 years；
- •children with weight for age within the normal range
- •were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes.
排除标准
- •Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
- •contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or midazolam;
- •with any nasal pathology,organ dysfunction;
- •recently respiratory infection, mental disorder;
- •other reasons that researchers hold it is not appropriate to participate in this trial.
研究组 & 干预措施
Midazolam
Patients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.
干预措施: Midazolam (Drug)
Dexmedetomidine
Patients were assigned to receive intranasal dexmedetomidine 2ug/kg approximately 30-40 minutes before surgery using a computer-generated random number table.
干预措施: Dexmedetomidine (Drug)
Midazolam and Dexmedetomidine
Patients were assigned to receive intranasal dexmedetomidine 1ug.kg-1 and oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.
干预措施: Midazolam and Dexmedetomidine (Drug)
结局指标
主要结局
The degree of cooperation during inhalation anesthesia induction
时间窗: During inhalation anesthesia induction
Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction
次要结局
- Anxiety before induction of anesthesia(Before preoperative medication)
- The onset time of satisfactory sedation(During the preoperative period)
- Parental separation anxiety scale(During the preoperative period)
- Recovery times(Within up to 30 minutes after child's first eye opening in the postoperative period)
- Pediatric anesthesia emergence delirium(Within up to 15-30 minutes after child's first eye opening in the postoperative period)
- The level of sedation(Each 10 minutes during the preoperative period)
- Number of children with adverse effects(Up to 24 hours including preoperative, intraoperative, and postoperative periods)