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Anesthetic Effects in Mitochondrial Disease

NCT01001585 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-03-09

No results posted yet for this study

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

Conditions

Interventions

DRUG

sevoflurane

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, which will take approximately 10 minutes.

Sponsors & Collaborators

  • d sessler

    lead OTHER

Principal Investigators

  • Danield I Sessler, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001585 on ClinicalTrials.gov