Evaluation of the Nociception Guided by NoL Index and Pharmacokinetics of Fentanyl in Pediatric Patients Under General Anesthesia for Non-cardiac Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- NoL index.
研究概览
简要总结
Fentanyl is one of the most common used opioids for analgesia during general anesthesia, however there are few studies that describe the relationship between its pharmacokinetics and pharmacodynamics, especially in the pediatric population. The monitoring of the analgesia component during general anesthesia has been traditionally by changes in patient's vital signs, with new devices that measure nociceptive indexes like the Nociception level (NoL) index currently being validated for adults. There is still lacking evidence with nociceptive indexes in the pediatric population.
Insufficient dose of opioids may cause sympathetic response, respiratory complications, development of persistent post-surgical pain and even prolonged hospitalization. In the other hand, and overdose of opioids may cause over sedation, postoperatory nausea and vomiting, respiratory depression, hyperalgesia and tolerance.
Given the lack of evidence on the Pharmacokinetic and pharmacodynamic (PK/PD) of fentanyl in this group of patients, has led to raise the development of this observational prospective study; which is to describe a PK/PD model of fentanyl in pediatric population, through evaluation of the NoL index, in patients submitted to elective general non-cardiac surgery.
详细描述
Patients will be invited to participate before surgery, the inclusion criteria will be revised and the informed consent will be signed by one of the parents or legal tutor.
In the operating room will be recorded demographic data and relevant background such as: Age, Weight, Size, BMI.
Afterwards, in the operating room, the patient will be monitored regularly: EKG, pulse oximetry, non invasive blood pressure.
Induction of anesthesia with sevoflurane 6% in 100% oxygen, once loss of consciousness, 2 peripheral IV lines will be installed, one for medication and the other in the contralateral arm for blood samples. After that, a laryngeal mask device (LMA) appropriate for the weight for the management of the airway. In addition, the EEG will be monitored through a frontal electroencephalographic monitoring (BIS) system and a NoL index sensor, both of which will be recorded throughout the surgery.
Once all monitors are installed, a caudal block with 0,5-1 ml of bupivacaine 0,25% will be performed, in the left decubitus lateral position. Ventilator and vaporizer adjustments for an EtCO2 of 35-40 mmHg and a BIS index of 50-60 with Sevoflurane. After 12 minutes, because of the latency of caudal block; surgeons may start. If an effective caudal block is proven, the study will continue; if there is movement of the child, laryngospasm or an increase of more than 10% in the base values of heart rate or blood pressure, the patient will be excluded from the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 3-10 years old
- •ASA I - II
- •Lower abdominal or urological surgery, requiring general anesthesia and caudal block
排除标准
- •Obese patients
- •ASA III - IV - V
- •Allergy to fentanyl
- •Emergency surgery
- •Patients with sleep apnea
- •Surgeries anticipated to have an increased volume exchange or transfusion
研究组 & 干预措施
Tetanic stimulation
Single arm study
干预措施: Fentanyl (Drug)
Tetanic stimulation
Single arm study
干预措施: Tetanic stimulation (Other)
结局指标
主要结局
NoL index.
时间窗: Since induction of anesthesia until emergence of anesthesia (one hour in average)
Variations in the NoL index (0-100). NoL has a range from 0-100, with 0 indicates no pain and 100 indicates worst pain. Data will also be analyzed using nonlinear mixed effect modeling (NONMEM)
Change of the plasmatic levels of fentanyl
时间窗: 5, 15, 30, 45, 75 until 120 minutes after one dose of fentanyl.
Describe the change of the levels of fentanyl plasmatic levels (ng/mL) measured by high pressure liquid chromatography (HPLC).
Peak Plasma Concentration (Cmax)
时间窗: 5, 15, 30, 45, 75 until 120 minutes after one dose of fentanyl.
Calculate maximum plasma concentration (Cmax) fentanyl plasma levels measured with high pressure fluid (HPLC) after a single bolus of fentanyl in enrolled pediatric patients.
次要结局
- Heart rate (bpm)(At time of surgery, up to 120 minutes)
- Hemodynamics(At time of surgery, up to 120 minutes.)
- Pulse oximetry(At time of surgery, up to 120 minutes.)
- Bispectral index(At time of surgery, up to 120 minutes)
- Pain in Visual analogue scale (0-10)(Every 15 minutes in the PACU, up to 120 minutes)
研究者
Francisco Cruzat
Principal Investigator
Pontificia Universidad Catolica de Chile