Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children: a Multicenter Prospective Double-blind Study (BISDEX TRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,508
- 试验地点
- 10
- 主要终点
- Effect of BIS monitoring on the incidence of postoperative nausea and vomiting
研究概览
简要总结
This study will investigate the impact of combining dexamethasone and bispectral index (BIS) monitoring on the incidence of postoperative nausea and vomiting, emergence delirium and recovery trajectories in children undergoing ear-nose-throat (ENT) surgery.
详细描述
Immediately after securing the airway, an electrode will be attached and BIS monitoring will begin. This will be used to control the depth of general anaesthesia throughout the entire surgical procedure, with the aim of achieving BIS values of 40-60.
Intervention group: Following the administration of dexamethasone at the same dos-age as in the control group, BIS monitoring will be initiated immediately, with the depth of general anaesthesia controlled to a BIS value of 40-60.
Control group: Once access to the vascular system has been secured, dexamethasone will be administered intravenously at a dose of 0.15 mg/kg body weight, up to a maxi-mum of 5 mg. A non-functional electrode for bispectral index (BIS) monitoring will then be attached to the patient's forehead. The depth of anaesthesia will be controlled based on the minimum alveolar concentration (target MAC: 1-1.1).
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, Investigator)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 2 to 8 years undergoing endoscopic adenoidectomy
- •parental/child consent
- •ASA I-II (American Society of Anaesthesiologists Physical Status)
- •no central nervous system (CNS) or gastrointestinal tract (GIT) disease
- •no corticosteroid medication
排除标准
- •Parent/child disapproval
- •ASA III and above (American Society of Anaesthesiologists Physical Status)
- •central nervous system (CNS) or gastrointestinal tract (GIT) disease
- •chronic corticosteroid therapy
结局指标
主要结局
Effect of BIS monitoring on the incidence of postoperative nausea and vomiting
时间窗: 24 hours
Effect of BIS monitoring on the incidence of postoperative nausea and vomiting within 24 hours after surgery under general anaesthesia. Vomiting is defined as the expulsion of gastric contents through the oral cavity. Nausea is defined for the purposes of this study using the Baxter Animated Retching Face (BARF) score of 4 or more.
次要结局
- Effect of BIS monitoring on the incidence of emergent delirium(1 hour from surgery)