Clinical Trial: Anesthetic Effects in Mitochondrial Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Anesthetic Effects in Mitochondrial Disease

Brief Summary:

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:

  1. Determine which molecular defects in mitochondrial function lead to alter sensitivity to the VA sevoflurane.
  2. 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 m

Detailed Summary:
Sponsor: d sessler

Current Primary Outcome: Measure cardiovascular stability and electrical brain activity during slow induction with sevoflurane. [ Time Frame: 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.


Original Primary Outcome: Determine which molecular defects in mitochondrial function lead to alter sensitivity to the VA sevoflurane. [ Time Frame: end point analysis, 2010 (anticipated) ]

Current Secondary Outcome: Use cardiovascular and electrical brain measurements to limit amount of sevoflurane and predict individual sensitivity. [ Time Frame: during induction ]

In addition, the investigators will correlate their sensitivity to the type of mitochondrial defect so that it may be possible to predict which patients are likely to have an increased sensitivity.


Original Secondary Outcome: Establish the relative safety of sevoflurane in treatment of patients with mitochondrial disease. [ Time Frame: end point analysis, 2010 (anticipated) ]

Information By: The Cleveland Clinic

Dates:
Date Received: October 21, 2009
Date Started: September 2006
Date Completion:
Last Updated: March 5, 2015
Last Verified: March 2015