Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients Undergoing Sevoflurane Anesthesia (BTIGER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 16
- 主要终点
- End-tidal Sevoflurane Concentration
研究概览
简要总结
The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
详细描述
This is a multi-center, prospective, observational, non-invasive, randomized controlled study to collect data to compare the performance of standard practice (SP) group with the BIS™ monitoring (BIS) group. Pediatric patients between the ages of 4 to 18 years undergoing routine sevoflurane general anesthesia with an expected surgical procedure duration of greater than 30 minutes will be recruited. If the surgery is less than 15 minutes, the data will continue to be collected, but will not be included in the data analysis and the subject will be replaced with an additional subject. General surgeries including abdominal, urological, orthopedic, or ophthalmological procedures with an American Society of Anesthesiologists physical status of I - III.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
盲法说明
Investigator will be blinded to the BIS value in the Standard Practice Group
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric Subjects (ASA physical status I or II or III) aged: 4 years to 18 years scheduled for procedures with sedation where the process of assessment will not interfere with the procedure, progress, or patient care
排除标准
- •Has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes, or other medical sensors
- •Known neurological disorder (e.g., epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, hemiplegia, demyelinating disorders, cerebral palsy, congenital anomalies of the brain or spinal cord, or other known neurologic disorders)
- •Severe developmental delay per assessment of investigator or report of parent/guardian
- •Airway abnormalities
- •Pregnancy; subjects of childbearing potential will have a urine screen for pregnancy before surgery
- •If the process of assessment will interfere with the procedure or the progress of the procedure
- •Taking psychoactive medications
- •Taking any medications that may have an impact on the Central Nervous System (CNS)
- •Planned use of any regional anesthesia; a local field block is not included in this exclusion and can be used at the discretion of the anesthesia provider
结局指标
主要结局
End-tidal Sevoflurane Concentration
时间窗: duration of maintenance of anesthesia
Average end tidal (expired) sevoflurane (ETSevo) concentration during anesthesia maintenance in pediatric patients ages 4 to 18 years. The ETSevo values from each group will be reported to show that the values are different between the BIS group when compared to the Standard Practice Group.
次要结局
- Number of Participants With Each Score on the Wong Baker Faces Scale(up to 4 hours following anesthesia administration)
- Modified Aldrete Score(up to 4 hours following anesthesia administration)
- Number of Participants With Reported Airway Reflexes(up to 4 hours following anesthesia administration)
- Clinical Anesthesia Assessment(up to 4 hours following anesthesia administration)