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Anesthetic Effects in Mitochondrial Disease

Primary Purpose

Mitochondrial Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sevoflurane
Sponsored by
d sessler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mitochondrial Disease focused on measuring mitochondrial disease, sevoflurane, mitochondrial disease and sevoflurane sensitivity

Eligibility Criteria

12 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients presenting to the operating room for muscle biopsy as part of their diagnostic workup for possible mitochondrial disease.

Exclusion Criteria:

  • 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 95.
  • Documented pulmonary disease.

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

slow induction with sevoflurane

Arm Description

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.

Outcomes

Primary Outcome Measures

Measure cardiovascular stability and electrical brain activity during slow induction with sevoflurane.
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.

Secondary Outcome Measures

Use cardiovascular and electrical brain measurements to limit amount of sevoflurane and predict individual sensitivity.
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.

Full Information

First Posted
October 21, 2009
Last Updated
March 5, 2015
Sponsor
d sessler
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1. Study Identification

Unique Protocol Identification Number
NCT01001585
Brief Title
Anesthetic Effects in Mitochondrial Disease
Official Title
Anesthetic Effects in Mitochondrial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
However, no intervention reduced the risk of major morbidity or 1 yr mortality
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
d sessler

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitochondrial Disease
Keywords
mitochondrial disease, sevoflurane, mitochondrial disease and sevoflurane sensitivity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigator
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
slow induction with sevoflurane
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure cardiovascular stability and electrical brain activity during slow induction with sevoflurane.
Description
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.
Time Frame
during induction
Secondary Outcome Measure Information:
Title
Use cardiovascular and electrical brain measurements to limit amount of sevoflurane and predict individual sensitivity.
Description
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.
Time Frame
during induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting to the operating room for muscle biopsy as part of their diagnostic workup for possible mitochondrial disease. Exclusion Criteria: 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 95. Documented pulmonary disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danield I Sessler, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Anesthetic Effects in Mitochondrial Disease

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