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Anesthetic Effects in Mitochondrial Disease

Study:

Anesthetic Effects in Mitochondrial Disease

Rationale:

n/a

Purpose:

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 may be able to predict which patients are likely to have an increased sensitivity.

Study Status: Terminated

Recruiting:
n/a

Condition Intervention Phase
Mitochondrial Disease Drug: sevoflurane N/A

Verified by Outcomes Research Consortium August, 2011

Sponsored by: Outcomes Research Consortium
Information provided by: Outcomes Research Consortium
ClinicalTrials.gov identifier: NCT01001585

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Supportive Care

Cleveland Clinic
Cleveland, Ohio 44195
United States

Danield I Sessler, MD., Study Chair

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
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