Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Incidence of postoperative negative behavior changes
研究概览
简要总结
The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium. The main questions are:
Dose esketamine lower the incidence of postoperative negative behavior changes compared to placebo? Dose esketamine lower the incidence of emergence delirium compared to placebo? Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium.
Participants will:
Receive intravenous esketamine or placebo (a look-alike substance that contains no drug) during anesthesia induction; Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 7, and 30
详细描述
Approximately half of children who undergo general anesthesia experience emergence delirium (ED) and postoperative negative behavioral changes (PNBC). There was a positive correlation between delirium during recovery and the change in negative behaviour after the operation.
Esketamine has sedative, analgesic and anti-traumatic stress effects. Based on literature analysis and preliminary trials, this study suggests that intraoperative use of low-dose esketamine may reduce the incidence of emergence delirium and postoperative negative behavior changes in children.
This prospective randomized controlled trial was conducted to compare the effect of intravenous esketamine in the incidence of emergence delirium and postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug) to provide a reference for optimizing clinical anesthesia medication regimens.
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
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of Aneshesiologists physical status I or II;
- •Aged 3-7 years;
- •Scheduled for elective tonsillectomy and (or) adenoidectomy.
排除标准
- •Parents refusing to allow their children to participate;
- •Intake of sedative or analgesic medication within 48 hours before surgery;
- •Developmental delay;
- •Psychosis;
- •Body mass index > 30 kg/m2;
- •Allergy to study drugs;
- •Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;
- •Any other conditions that precluded study inclusion.
研究组 & 干预措施
Esketamine group
During anesthesia induction, 0.2 mg/kg esketamine was administered intravenously.
干预措施: Esketamine hydrochloride (Drug)
Control group
During anesthesia induction, an equal volume of 0.9% saline was administered intravenously.
干预措施: normal saline (Drug)
结局指标
主要结局
Incidence of postoperative negative behavior changes
时间窗: Postoperative day 7
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
次要结局
- Incidence of postoperative negative behavior changes(Postoperative day 30)
- Incidence of emergence delirium(Within 30 minutes after extubation)
- Postoperative pain intensity(Within 30 minutes after extubation)
- Preoperative anxiety(Before the intervention in holding area)
- Emergence time(About up to 30 minutes postoperatively)
- Parental satisfaction(Postoperative day 1)
- Length of postanesthesia care unit stay(Up to 60 minutes postoperatively)
- Incidence of adverse events(Up to 24 hours postoperatively)
研究者
Yao Yusheng
Clinical Professor
Fujian Provincial Hospital