Frontal Electroencephalography of Neonatal Patients Under Sedation With Opioids and General Anesthesia With Propofol.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Electroencephalography monitoring slow bands
研究概览
简要总结
Frequently, neonates hospitalized in neonatology units require anesthesia for surgery. The drugs used for this purpose are opioids and other anesthetics, such as propofol.
Currently, the administration of anesthesia is difficult in neonates due to the neurological immaturity of these patients, the scarcity of adequate pharmacological studies, the prolonged use of one or more sedatives prior to surgery and the limited usefulness of current anesthetic monitoring devices in this population.
Electroencephalography (EEG), which has allowed estimation of anesthetic depth in other populations, has been less explored in neonates. To date, there are no EEG markers, correlated with a given dose of anesthesia, that allow an adequate administration in this kind of patients. In this context, a better understanding of the anesthetic effect in the neonatal brain would allow defining characteristic EEG patterns, improving the estimation of anesthetic depth and anesthetic dosage in neonates.
详细描述
As a consequence of the cerebral immaturity of newborns (1,2), together with the fact that in the NICU it is common to find patients requiring surgery who are sedated with multiple drugs, it is necessary to define characteristic EEG patterns that allow estimation of the anesthetic depth and adequate dosage of anesthetics, avoiding the the risk of under- or overdosing of anesthetics (3).
The investigators will conduct an exploratory study. The aim of the study is to determine, by frontal electroencephalography, markers of brain electrical activity associated with the administration of propofol in term newborns requiring surgery in the NICU. A sample of 20 term neonatal patients admitted to the NICU UC with a diagnosis of surgical pathology will be included.
General objective:
To describe the characteristics of the frontal electroencephalographic pattern associated with increasing doses of propofol, in term neonates, requiring surgery in the NICU and its correlation with a clinical response, to the surgical stimulus.
Specific objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term newborns (>37 weeks) admitted to the NICU
- •Diagnosis of surgical pathology, non-neurological, to be resolved in the NICU, in the next hours or days.
- •Need for continuous sedation-analgesia prior to surgery.
- •Exclusion criteria:
- •Perinatal asphyxia
- •Evidence of severe neurological injury.
- •Suspected or diagnosed brain malformations
- •Uncontrolled metabolic and hemodynamic instability at the time of surgery.
排除标准
- 未提供
研究组 & 干预措施
Propofol Group 3
Patients will receive induction of anesthesia with Propofol at a rate of 6.0 mg/kg/hr.
干预措施: Propofol Group 3 (Drug)
Propofol Group 1
Patients will receive induction of anesthesia with Propofol at a rate of 2.0 mg/kg/hr.
干预措施: Propofol Group 1 (Drug)
Propofol Group 2
Patients will receive induction of anesthesia with Propofol at a rate of 4.0 mg/kg/hr.
干预措施: Propofol Group 2 (Drug)
Propofol Group 4
Patients will receive induction of anesthesia with Propofol at a rate of 8.0 mg/kg/hr.
干预措施: Propofol Group 4 (Drug)
结局指标
主要结局
Electroencephalography monitoring slow bands
时间窗: 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Power of frequency slow bands, entropy and complexity measures.
Electroencephalography monitoring Theta bands
时间窗: 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Power of frequency Theta bands, entropy and complexity measures.
Electroencephalography monitoring alpha bands
时间窗: 10 minutes before the induction of anesthesia until 10 minutes after emergence of anesthesia, average of 2 hours
Power of frequency alpha bands, entropy and complexity measures.
次要结局
- Heart Rate(From induction of anesthesia until surgery starts, average 20 minutes.)
- Arterial Pressure(From induction of anesthesia until surgery starts, average 20 minutes.)
- Depth of anesthesia(before the induction of anesthesia until the surgery starts, every 10 minutes. An average of 30 minutes.)
- Propofol plasma concentration(from induction of anesthesia up to 20 minutes.)
- Motor response to surgical incision(at first surgical incision (average 1 minute).)