Efficacy of Dexmedetomidine on Emergence Delirium in Children Undergoing Adenotonsillectomy: A Double-Blind Randomized Controlled Trial with Heart Rate Variability and Electroencephalography-Guided Anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Emergence delirium (ED), defined as a Pediatric Anesthesia Emergence Delirium (PAEDs) score ≥ 10 in the time between waking up, until 45 minutes after waking up; measured at 15, 30, and 45 minutes after waking up, or whenever there are signs of ED within this time frame. This is a dichotomous endpoint recorded as "ED present" if PAEDs score ≥ 10 and "absent” otherwise.
研究概览
简要总结
To evaluate if dexmedetomidine reduces the risk of emergence delirium in children aged 1-7 years old undergoing adenotonsillectomy during general anesthesia guided by heart rate variability and electroencephalogram monitoring.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists I and II
- •Children aged 1–7 years
- •Scheduled to undergo adenotonsillectomy
排除标准
- •Known allergies or intolerances to Dexmedetomidine
- •Acute cerebrovascular conditions
- •Clinically unfit for general anesthesia
- •Neuropsychiatric diagnoses that include: intellectual disabilities, disorders of psychological development, and behavioural and emotional disorders with onset usually occurring in childhood and adolescence. As defined in ICD-10, F70 to F
- •Daily use of analgesics
- •Under investigation for a neuropsychiatric diagnosis as defined in exclusion point number
- •Children whose legally authorized representative does not speak and read sufficient Norwegian or English.
- •Missing consent from the participant’s legally authorized representatives
- •Second- or third-degree atrioventricular block, unless the patient has a pacemaker.
- •Uncontrolled hypotension
研究组 & 干预措施
Natriumklorid B. Braun 9 mg/ml oppløsningsvæske til parenteral bruk
干预措施: Natriumklorid B. Braun 9 mg/ml oppløsningsvæske til parenteral bruk (Drug)
Dexmedetomidine B. Braun 100 mikrogram/ml konsentrat til infusjonsvæske, oppløsning
干预措施: Dexmedetomidine B. Braun 100 mikrogram/ml konsentrat til infusjonsvæske, oppløsning (Drug)
结局指标
主要结局
Emergence delirium (ED), defined as a Pediatric Anesthesia Emergence Delirium (PAEDs) score ≥ 10 in the time between waking up, until 45 minutes after waking up; measured at 15, 30, and 45 minutes after waking up, or whenever there are signs of ED within this time frame. This is a dichotomous endpoint recorded as "ED present" if PAEDs score ≥ 10 and "absent” otherwise.
Emergence delirium (ED), defined as a Pediatric Anesthesia Emergence Delirium (PAEDs) score ≥ 10 in the time between waking up, until 45 minutes after waking up; measured at 15, 30, and 45 minutes after waking up, or whenever there are signs of ED within this time frame. This is a dichotomous endpoint recorded as "ED present" if PAEDs score ≥ 10 and "absent” otherwise.
次要结局
- Emergence delirium, defined as a Richmond Agitation-Sedation Scale score > 0 in the time between waking up, until 45 minutes after waking up; measured at 15, 30, and 45 minutes after waking up or whenever there are signs of emergence delirium within this time frame. This is a dichotomous endpoint recorded as "emergence delirium present" if Richmond Agitation-Sedation Scale score > 0 and "absent” otherwise.
- Level of pain during the first 45 minutes after waking up will be measured with the Face Legs Activity Cry Consolation score, Nurse Numeric Rating Scale score, and Parental Numeric Rating Scale score.
- Level of pain during the stay in the Post-Anesthesia Care Unit. Measured with total opioid analgesic consumption.
- Length of stay during anesthesia and in the Post-Anesthesia Care Unit. Departure from the Post-Anesthesia Care Unit will follow the local discharge criteria.
- Postoperative nausea and vomiting in the Post-Anesthesia Care Unit and in the initial 24-hour postoperative period will be measured with the Baxter Retching Faces scale.
- The parental satisfaction score will be measured with the Pediatric Anesthesia Parent Satisfaction score.
- The frequency of adverse events, after investigestional medicinal product administration, in the intervention groups.
- The frequency of systolic blood pressure hypotension, after investigestional medicinal product administration, in the intervention groups.
研究者
Department of Anesthesiology and Intensive Care.
Scientific
Akershus University Hospital