Remifentanil for endotracheal intubation in neonates: a dose-finding trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Successful outcome is defined as adequate intubation with satisfactory sedation. Following each procedure: intubating conditions are graded immediately by the intubator with a scoring system based on criteria for good clinical research practice (GCRP) by Viby-Mogensen. Each assessment domain is allocated a score of 1-4. Good quality of intubation was defined as a score of ≤ 2 on each of the 5 items.
研究概览
简要总结
Because data on optimal remifentanil dosing and its pharmacodynamic effects (PD) in preterm and term neonates are limited we will perform a prospective dose-finding study with PD assessment in neonates receiving remifentanil as premedication for semi-elective endotracheal intubation. The primary outcome measure is to determine the age-specific bolus dose of remifentanil (ED90) that provides adequate intubating conditions (effective sedation) in 90% of subjects with minimal side effects.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Hemodynamic stable term or preterm neonate (normal mean blood pressure, without use of inotropic agents or vasopressors.
- •Requiring semi-elective endotracheal intubation.
- •Minimum of 26 weeks gestational age.
- •Written informed consent obtained from the legal representatives.
排除标准
- •5th min Apgar score less than
- •Maxillofacial anomalies.
- •Anticipated difficult airwaiy (e.g. airway anomaly or obstruction).
- •Concurrent or recent intravenous opioids infusions within 24 hours of the procedure.
- •Neonates from non-Dutch speaking parents
- •Infants born via cesarian section under general anesthesia 12 hours prior to enrollment.
- •Neonates from mothers with recent drug abuse
- •Prior enrollment in the trial.
结局指标
主要结局
Successful outcome is defined as adequate intubation with satisfactory sedation. Following each procedure: intubating conditions are graded immediately by the intubator with a scoring system based on criteria for good clinical research practice (GCRP) by Viby-Mogensen. Each assessment domain is allocated a score of 1-4. Good quality of intubation was defined as a score of ≤ 2 on each of the 5 items.
Successful outcome is defined as adequate intubation with satisfactory sedation. Following each procedure: intubating conditions are graded immediately by the intubator with a scoring system based on criteria for good clinical research practice (GCRP) by Viby-Mogensen. Each assessment domain is allocated a score of 1-4. Good quality of intubation was defined as a score of ≤ 2 on each of the 5 items.
The level of sedation is assessed with a sedation score (adopted from the study of Naulaers et al) performed by rubbing the sole of the subject’s foot and judging the motor reaction to that stimulus (1 = spontaneous movement; 2 = movement on slight touch; 3 = movement in reaction to firm stimulus; 4 = no movement).
The level of sedation is assessed with a sedation score (adopted from the study of Naulaers et al) performed by rubbing the sole of the subject’s foot and judging the motor reaction to that stimulus (1 = spontaneous movement; 2 = movement on slight touch; 3 = movement in reaction to firm stimulus; 4 = no movement).
次要结局
- safety end points: During the intubation procedure: predefined side effects such as bradycardia (heart rate less than 100 bpm), hypotension, respiratory depression, and chest wall rigidity are reviewed..
- efficacy end points: ease of bag-mask ventilation and time to successful intubation
- additional end points: time to return of spontaneous ventilation ; incidence of intraventricular hemorrhage ; blood gas values ; need for rescue medication
研究者
Lara Garabedian
Scientific
Universitair Ziekenhuis Gent