Influence of Monitoring the Depth of General Anesthesia Upon the Incidence of PONV and Emergence Delirium in Children Undergoing Endoscopic Adenoidectomy in General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of PONV
研究概览
简要总结
The study has been designed as a prospective randomized clinical trial. Due to the use of a bispectral (BIS) monitor in the interventional arm, the study will not be blinded for the anesthetist. The total planned number of study subjects is 100. Patients will be randomly randomized upon arrival to the operating theatre (using the envelope method) into the interventional arm (BIS monitoring of the depth of general anesthesia), and into the control group (standard management of general anesthesia to minimum alveolar concentration (MAC) 1,0). The target values of the depth of general anesthesia according to BIS are between 40 and 60.
详细描述
The condition of postoperative nausea and vomiting (PONV) is defined as nausea and vomiting, which appears within 24 hours after the performance of a surgical/diagnostic procedure in general anesthesia. PONV is perceived as a complication of minor importance in perioperative medicine, nevertheless, it is one of the most frequent causes of morbidity in pediatric patients in the early postoperative period, associated with a number of adverse effects. The incidence of PONV in pediatric age is reported in scientific literature to be between 8.9 and 42 percent. The pathogenesis of PONV is complex and has not been fully clarified yet. The development of PONV depends on individual and anaesthesiology risk factors, and the type of surgical procedure. The use of inhalation anesthetics demonstrably increases the incidence of PONV, especially in the course of the first two hours after the procedure. The need for inhalation anesthetic is individually variable, and it is not possible to empirically define, which dose will lead to an adequate depth of anesthesia. Excessively deep, as well as too shallow anesthesia may result in increasing the incidence of postoperative complications, including PONV. The depth of anesthesia and unconsciousness may be monitored with BIS (bispectral index). The investigators presume that optimization of the supply of inhalation anesthetic according to BIS, so-called BIGA (Bispectral index guided anesthesia) will lead to decreasing the incidence of PONV.
Several clinical studies performed on the adult population have demonstrated that using BIGA leads to a decreased incidence of PONV in adult patients undergoing gynecological procedures. As far as pediatric anesthesiology is concerned, similar studies are still lacking.
Inhalation anesthesia is also associated with another complication in the early postoperative period - so-called emergence delirium (ED). It is a condition of psychomotor restlessness, perception disorders, and excitation of the child observed after completion of anesthesia. The incidence of ED in the pediatric population anesthesia is between 10 and 80 percent, most frequently within the first 10-30 minutes after discontinuation of the administration of anesthetics. The condition is characterized by confusion, loss of orientation, crying, restlessness, and non-cooperation of the child. The causes of ED have not been fully clarified.
One of the possible causes may be the rapid emergence of the child from anesthesia after discontinuation of the inhalation anesthetic. The incidence of ED is highest with Sevoflurane, which is the most frequently used inhalation anesthetic in pediatric anesthesia. Optimization of the depth of general anesthesia and decreasing the consumption of inhalation anesthetic may lead to decreasing the incidence of emergence delirium objectified according to the Paediatric Anaesthesia Emergence Delirium (PAED) score.
The study has been designed as a prospective randomized clinical trial. Due to the use of the BIS monitor in the interventional arm, the study will not be blinded for the anesthetist. The total planned number of study subjects is 100. Patients will be randomly randomized upon arrival to the operating theatre (using the envelope method) into the interventional arm (BIS monitoring of the depth of general anesthesia), and into the control group (standard management of general anesthesia to minimum alveolar concentration (MAC) of 1.0). The target values of the depth of general anesthesia according to BIS are between 40 and 60.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking is being used in this study.
入排标准
- 年龄范围
- 3 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3-8 years of age
- •Indication for the performance of endoscopic adenoidectomy in general anesthesia
- •ASA I a II
- •Consent of a parent/a guardian
排除标准
- •ASA III and more
- •Disapproval of a parent/a guardian
- •Disapproval of the patient
- •Allergies to medication used in the course of the study
- •Contraindication of inhalation introduction to anesthesia and the way of securing breathing passageways in the study, according to the attending anesthetist
结局指标
主要结局
Incidence of PONV
时间窗: During the hospitalisation of the patient, i.e. up to 5 days
The incidence of PONV will be observed and recorded using the Baxter Reetching Faces (BARF) scale and recording the number of PONV episodes.
Incidence of ED
时间窗: During the hospitalisation of the patient, i.e. up to 5 days
The incidence of ED will be observed and recorded using the PAED score.
次要结局
未报告次要终点
