Use of Bispectral Index (BIS) Monitoring of Anaesthesia With Propofol and Remifentanyl in Pediatric Patients in Ear Nose and Throat Surgery: Are There Clinical Advantages?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Time to extubation since the interruption in the administration of anaesthetics.
研究概览
简要总结
The objective of the study is to determine wether the use of the Bispectral Index Monitor (BIS) as a method to guide anaesthesia for children in different groups of age, undergoing ear nose and throat surgery anaesthetized with an infusion of Propofol and Remifentanil with an high dose of Remifentanil (0,5-2 mcg/kg/min), can lead to a reduction in the time needed for extubation and in the amount of anesthetics used.
详细描述
The participants to the study are patients undergoing the following operations: Tonsillectomy, Adenoidectomy, Microlaryngoscopy, Bronchoscopy, Esophagoscopy, Myringoplasty, Myringotomy with positioning of a tube.
All these procedures are performed with the patient receiving a general anesthesia with and infusion of Propofol and Remifentanil. Muscle relaxants and inhaled anesthetics are not used.
The patients undergoing a Tonsillectomy will receive a supplementary opioid analgesic (Inj. Fentanyl iv, 3mcg/kg) at the end of the surgical procedure. Patients undergoing the other operations receive intraoperative Paracetamol and NSAID for postoperative pain treatment.
Stratification by age (1-3y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects. Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status 1 or 2
- •General anesthesia for the following operations: Tonsillectomy, Adenoidectomy, Myringoplasty, Myringotomy with tube placement, microlaryngoscopy, bronchoscopy and esophagoscopy.
排除标准
- •Psychiatric disorder
- •Use of psychotherapeutic, antiepileptic, antiarrhythmic drugs
- •Chronic use of opioids
- •Intake of more than 21 alcoholic drinks/week
- •Missing informed consent
研究组 & 干预措施
Control
Patients receive general anesthesia with Propofol and Remifentanil following clinical practice.
Stratification by age (1-3 y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects.
Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.
干预措施: Propofol (Drug)
Control
Patients receive general anesthesia with Propofol and Remifentanil following clinical practice.
Stratification by age (1-3 y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects.
Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.
干预措施: Remifentanil (Drug)
Bispectral Index Monitor
Patients receive a general anesthesia with Propofol and Remifentanil where the amount of anesthetics administered is decided taking into consideration the Bispectral Index Monitor.
Stratification by age (1-3 y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects.
Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.
干预措施: Propofol (Drug)
Bispectral Index Monitor
Patients receive a general anesthesia with Propofol and Remifentanil where the amount of anesthetics administered is decided taking into consideration the Bispectral Index Monitor.
Stratification by age (1-3 y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects.
Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.
干预措施: Remifentanil (Drug)
Bispectral Index Monitor
Patients receive a general anesthesia with Propofol and Remifentanil where the amount of anesthetics administered is decided taking into consideration the Bispectral Index Monitor.
Stratification by age (1-3 y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects.
Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.
干预措施: Bispectral Index Monitor (Device)
结局指标
主要结局
Time to extubation since the interruption in the administration of anaesthetics.
时间窗: 30 minutes-3 hours
次要结局
- Consumption of Remifentanil at induction and during maintenance of general anesthesia.(30 minutes-3 hours)
- Average BIS during the surgical procedure(30min-3hours)
- Consumption of Propofol during the induction and maintenance of anesthesia.(30 minutes-3 hours)
研究者
Piergiorgio Bresil
MD
Aalborg University Hospital