Intranasal Remimazolam for Premedication in Pediatric Patients: a Double-blinded Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The level of anxiety
研究概览
简要总结
Anesthetic inhalation induction could be one of the most stressful experiences for children during the perioperative period, with almost 50% of them showing anxiety. It is an essential challenge for pediatric anesthesiologists on how to decrease anxiety for children in the operating room (OR) environment and to facilitate a smooth induction of anesthesia. Various factors like parental separation, unfamiliar surroundings, fear of physicians and needle injections can increase their preoperative anxiety. The researchers conducted the current study to investigate whether intranasal remimazolam can reduce anxiety in children before surgery.
详细描述
children aged 2-5 years old were randomly allocated into three equal groups based on the premedication routes: Group R with intranasal remimazolam, Group D with intranasal dexmedetomidine and Group P with intranasal placebo, respectively.
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 5 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 2-5 years；
- •children with weight for age within the normal range
- •were scheduled surgery with general anesthesia
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 remimazolam;
- •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
group P (Placebo group)
intranasal placebo about 30min before anesthesia induction
干预措施: Distilled water for injection (Other)
group R (remimazolam group)
intranasal remimazolam about 30min before anesthesia induction
干预措施: Remimazolam (Drug)
group D (Dexmedetomine group)
intranasal dexmedetomidine about 30min before anesthesia induction
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The level of anxiety
时间窗: up to 30 minutes after study drug given
The Modified Yale Preoperative Anxiety Scale: The 22-item measure has five behavioural categories: activity, emotional expressivity, alertness and arousal, vocalizations, and interaction with parents. Total scores range from 23.33 through 100 with higher scores indicating greater anxiety.
次要结局
- The level of sedation(up to 30 minutes after study drug given)
- the compliance of study drug given(up to 30 minutes before anesthesia induction)
- Pediatric anesthesia emergence delirium scale，PAEDs(Within up to 15-30 minutes after child's first eye opening in the postoperative period)
- Number of children with adverse effects(Up to 24 hours including preoperative, intraoperative, and postoperative periods)
- Parental separation anxiety scale(up to 30 minutes after study drug given)
- The degree of cooperation during inhalation anesthesia induction(intraoperative, (During inhalation anesthesia induction))
- Mask acceptance scale，MAS(intraoperative, (During inhalation anesthesia induction))
- Recovery times(Within up to 30 minutes after child's first eye opening in the postoperative period)