Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 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 are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. There are many ways to relieve pediatric anxiety, including preoperative medication, games, and cartoons. Preoperative medication is the most commonly used method to relieve pediatric anxiety.The most commonly used pediatric preoperative sedation drugs are midazolam and esketamine.However, oral midazolam may not produce a sedative effect in 20-40% of patients. A good preoperative anxiety-reducing effect was seen in only 60-80% of cases.Therefore, this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone. This will provide a reference for the selection of safe, reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care.
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
- Double (Participant, Outcomes Assessor)
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 esketamine 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)
esketamine
Patients were assigned to receive intranasal esketamine 1mg/kg approximately 30-40 minutes before surgery using a computer-generated random number table.
干预措施: Esketamine (Drug)
midazolam and esketamine
Patients were assigned to receive intranasal esketamine 0.6mg/kg and oral midazolam 0.3mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.
干预措施: midazolam and esketamine (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
- The level of sedation(Each 10 minutes during the forty minutes of 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)
- Anxiety before induction of anesthesia(Each 10 minutes during the forty minutes of preoperative period)
- Number of children with adverse effects(Up to 24 hours including preoperative, intraoperative, and postoperative periods)