Effect of Nebulized Dexmedetomidine on Gag Reflex Suppression in Pediatric Upper Gastrointestinal Endoscopy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- gag reflex
研究概览
简要总结
This study aims to demonstrate that the application of nebulized dexmedetomidine to patients during pediatric upper gastrointestinal endoscopic procedures will significantly reduce the gag reflex and enhance both patient and practitioner comfort
详细描述
Due to the intolerance of pediatric patients to the insertion of the endoscopic probe during upper gastrointestinal procedures, sedation and analgesia are required. In this patient group, the reflex to vomit is common during probe placement. Discomfort, pain, and hemodynamic changes can occur due to the vomiting reflex. In fact, this situation can lead to serious complications such as esophageal rupture. Inappropriate sedation conditions may result in increased post-procedural pain and agitation in patients.
Therefore, various sedative drugs are used for procedural sedation in pediatric patients. The use of these drugs during gastrointestinal endoscopy in the pediatric population can vary in terms of sedative, hemodynamic, respiratory, and side effects.
Dexmedetomidine, a highly selective alpha-2 agonist with central sedative and anxiolytic properties, has been tested in children for preoperative anxiolysis through nasal and inhalation routes. Due to its bioavailability of up to 82%, it is well absorbed systemically through oral and buccal routes.' It possesses sedative, analgesic, sympatholytic, and hemodynamic stability properties. Even at high doses, it has a unique feature of not causing respiratory depression, which gives it an advantage over other sedatives such as benzodiazepines, opioids, and propofol, all of which can cause dose-dependent respiratory depression. In this regard, it may be a good alternative for procedures like gastrointestinal endoscopy.
Based on these considerations, the investigators plan to conduct a randomized controlled study hypothesizing that nebulized dexmedetomidine as premedication in pediatric patients undergoing gastrointestinal endoscopy will significantly reduce the gag reflex.
108 patients will be included in the study. Patients will be divided into 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I and II
- •2 to 17 years of age,
- •Patient undergoing in Upper Gastrointestinal Endoscopy
排除标准
- •Patients with heart disease
- •Patients with mental-motor retardation
- •Patients with abnormal upper respiratory tract
- •Patients with a history of asthma
- •Patients with upper respiratory tract history in the last 4 weeks
- •Patients with severe sleep apnea on polysomnography
- •ASA >III patients
- •Patients with drug allergies
研究组 & 干预措施
Group C
Control group
干预措施: a routine sedation protocol (Other)
Group ND
Nebulisation with dexmedetomidine
干预措施: Nebulized with dexmedetomidine (Drug)
结局指标
主要结局
gag reflex
时间窗: through endoscopic procedure up to one hour
This will be assessed when a vomiting like response will provoked upon introduction of the endoscope.
次要结局
- Adverse effects(2 hours post the procedure)
- Depth of sedation(During Procedure (after 1 minute of induction of sedation and allover the time of the procedure every 2 or 3 minutes))
- Endoscopist's level of satisfaction with regard to the occurrence of gagging and the challenges encountered during the procedure(through endoscopic procedure up to one hour)
研究者
Esra Turunc
Study director
Ondokuz Mayıs University