Anesthetic Effects in Mitochondrial Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Measure cardiovascular stability and electrical brain activity during slow induction with sevoflurane.
研究概览
简要总结
Summary. At the present, the investigators do not have the perfect anesthetic for mitochondrial patients. When possible, consideration should be given to the use of local anesthetics in small amounts. When a general anesthetic is necessary, they each carry significant risks and have been associated with poor outcomes. At present it is not possible to eliminate one group as less safe than others. What is clear is that these patients must be monitored more closely than other patients. The advent of the bispectral index (BIS) monitor may allow us to monitor their depth of anesthesia more closely and thus expose these patients only to the minimum amount of drug necessary to carry out the surgical procedure.
Purpose. The investigators hypothesize that specific mitochondrial diseases, in particular those that decrease complex I function, make certain children hypersensitive to volatile anesthetics. These same patients may be at increased risk for adverse outcomes following general anesthesia. The specific aims of this application are:
- Determine which molecular defects in mitochondrial function lead to alter sensitivity to the VA sevoflurane.
- Establish the relative safety of sevoflurane in treatment of patients with mitochondrial disease.
The investigators plan to monitor patients with mitochondrial disease using expanded measures of cardiovascular stability and measurements of brain electrical activity while slowly inducing general anesthesia. The investigators will use those measurements to limit the amount of anesthetic these patients receive in an attempt to minimize their risk. In addition, the investigators will correlate their sensitivity to the type of mitochondrial defect so that the investigators may be able to predict which patients are likely to have an increased sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to the operating room for muscle biopsy as part of their diagnostic workup for possible mitochondrial disease.
排除标准
- •Patients more than 16 years of age.
- •Patients with concurrent acute infectious disease.
- •Patients not tolerating a slow induction for emotional reasons.
- •Initial BIS measurement of less than
- •Documented pulmonary disease.
研究组 & 干预措施
slow induction with sevoflurane
Only children with a BIS greater than 95 prior to inhalation of sevoflurane will be included in the study. Inductions will be done using a tight fitting mask with continuous monitoring of end tidal gas concentrations. During induction, concentration of inspired sevoflurane will begin at .5%, and slowly increased by 0.5% every two minutes, until a Bispectral Index (BIS) of 60 or less is reached. Inspired sevoflurane will be increased only after end tidal concentration of sevoflurane is constant for at least one minute. Each induction (except for the patients requiring very low doses of sevoflurane) will take approximately 10 minutes.
干预措施: sevoflurane (Drug)
结局指标
主要结局
Measure cardiovascular stability and electrical brain activity during slow induction with sevoflurane.
时间窗: during induction
The investigators plan to monitor patients with mitochondrial disease using expanded measures of cardiovascular stability and measurements of brain electrical activity while slowly inducing general anesthesia. The investigators will use those measurements to limit the amount of anesthetic these patients receive in an attempt to minimize their risk.
次要结局
- Use cardiovascular and electrical brain measurements to limit amount of sevoflurane and predict individual sensitivity.(during induction)
研究者
d sessler
Medical Doctor
The Cleveland Clinic