Effects of Nasal Administration of Dexmedetomidine on Pre-Anesthesia Sedation, Intraoperative Brain Electrical Activity, and Incidence of Agitation During Recovery in Children: a Multicenter, Large Sample, Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 627
- 主要终点
- Success rate of preoperative sedation
研究概览
简要总结
Pre - operative anxiety and emergence agitation are common issues among pediatric patients, which have various influences on the recovery progress and prognosis of children. Nasal administration of dexmedetomidine is a convenient and non - invasive sedation technique for children. This technique can reduce the incidences of pre - operative anxiety and emergence agitation. However, there are few studies on the effect of dexmedetomidine on intraoperative electroencephalographic activities.
In view of this, the investigators elaborately designed a prospective, multi - center, large - sample - sized, double - blind, randomized - controlled clinical trial. This trial aims to provide a basis for drug selection in pediatric anesthesia, ensuring the safety and comfort of pediatric anesthesia.
The investigators plan to select 627 participants who will undergo minor surgeries under general anesthesia. Thirty minutes before the surgery, dexmedetomidine or normal saline will be administered nasally to these participants. Before the surgery, the anxiety degree and sedation score of the participants will be assessed; during the surgery, the cooperation degree of patients during anesthesia induction will be evaluated and electroencephalographic monitoring will be carried out; after the surgery, the incidence of emergence agitation, the recovery time and the analgesic score of the participants will be assessed. Throughout the whole process, the occurrence of adverse reactions of participants will be fully monitored, and the adverse reactions will be timely recorded and treated.
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
- Triple (Participant, Investigator, 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
- •2≤ age ≤6 years old, gender is not limited;
- •ASA anesthesia grade I ~ II; ③ For children who intend to undergo minor surgery under general anesthesia (including but not limited to minor surgery such as ENT surgery and hernia surgery), the operation duration is expected to be no more than 2 hours; ④ Family members agree to participate in the study and voluntarily sign informed consent;
排除标准
- •Respiratory tract infection occurs within 4 weeks before surgery;
- •Potential or other contraindications to general anesthesia;
- •There are nasal diseases, nasal bleeding, sinusitis, nasal polyps and other conditions that affect nasal absorption; ④ Heart, liver, kidney and other vital organ dysfunction or blood system diseases;
- •Allergy or intolerance to dexmedetomidine or other α2-adrenergic receptor agonists;
- •Patients with mental illness or neurological diseases;
- •Unable to complete the test, the child's guardian refused to participate; ⑧ Have participated in other clinical trials or need to participate in other clinical trials during the study period; ⑨ Other reasons that the researchers consider inappropriate to participate in this study.
研究组 & 干预措施
Dexmedetomidine
干预措施: Preoperative sedation with dexmedetomidine was administered nasal before surgery (Drug)
Placebo
干预措施: Preoperative sedation with normal saline was administered nasal before surgery (Drug)
结局指标
主要结局
Success rate of preoperative sedation
时间窗: 30 minutes before medication on the day of surgery
Successful sedation was considered when participants received Ramsay sedation score ≥3 on the sedation scale 30 minutes after medication.
Incidence of emergence agitation
时间窗: After extubation, patients were evaluated every 15 minutes until they were sent out of the recovery room, approximately 15 minutes to 1 hour.
Immediately after extubation, the Pediatric Anesthesia Emergence Delirium (PAED) Scale and the 5-Point Agitation Scale for Emergence Agitation were used to assess the level of postoperative emergence agitation (EA) in the participants. Subsequent assessments were conducted every 15 minutes until the participants was transferred back to the ward. A PAED score ≥ 12 or a 5-Point Agitation Scale score \> 3 could be diagnosed as emergence agitation.
Intraoperative brain electrical activity differences
时间窗: 5 minutes after the end of anesthesia induction until the patient is sent out of the operating room,approximately 45 minutes to 2 hours.
The characteristics of four kinds of brain wave α, β ,δ and θ were analyzed by professional EEG analysis software
次要结局
- Preoperative anxiety(Before,15 minutes and 30 minutes after administration)
- Degree of cooperation in anesthesia induction(After entering the operation room to before anesthesia induction,approximately 3 minutes.)
- Postoperative recovery time(A period of time beginning after the withdrawal of narcotic drugs until the patient regains self-consciousness and can respond correctly to external stimuli, approximately 15 minutes to 1 hour.)
- Incidence of delayed recovery(30 minutes after surgery.)
- Postoperative analgesia score(Immediately after recovery, the patients were re-evaluated every 15 minutes until they were sent out of the recovery room, approximately 15 minutes to 1 hour.)
- Incidence of adverse reactions(Between the time the patient is sent out of the recovery room after preoperative administration, approximately 2 to 3 hours..)
研究者
Fuzhou Hua
Chief Physician
Second Affiliated Hospital of Nanchang University