Mitochondrial DiseaseNCT01001585
Anesthetic Effects in Mitochondrial Disease
A study testing sevoflurane in people with Mitochondrial Disease, run by d sessler at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 16 years
- Conditions the study is for
- Mitochondrial Disease
- What is being tested?
- sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients presenting to the operating room for muscle biopsy as part of their diagnostic workup for possible mitochondrial disease.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- Conditions
- Mitochondrial Disease
- Being tested
- sevoflurane
- Keywords
- mitochondrial disease, sevoflurane, mitochondrial disease and sevoflurane sensitivity
- Medical subject headings
- Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| slow induction with sevoflurane | Experimental | 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. Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during induction
Secondary outcomes (1)
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.
Measured: during induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2011
- Study completionOct 2011
Why it stopped: However, no intervention reduced the risk of major morbidity or 1 yr mortality
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- d sessler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, d sessler, The Cleveland Clinic
- Investigators
- Danield I Sessler, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001585
- Sponsor's protocol ID
- 06-644
- Status last verified
- Mar 2015
- First submitted
- 21 Oct 2009
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Effects in Mitochondrial Disease
- ClinicalTrials.gov ID
- NCT01001585
- Acronym / sponsor ID
- 06-644
- Conditions
- Mitochondrial Disease
- Keywords
- mitochondrial disease, sevoflurane, mitochondrial disease and sevoflurane sensitivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: However, no intervention reduced the risk of major morbidity or 1 yr mortality
- Enrolment
- 55 participants (actual)
- Lead sponsor
- d sesslerUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| slow induction with sevoflurane | Experimental | Drug: sevofluraneOnly 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. |
Who may qualify
- Ages
- 12 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients presenting to the operating room for muscle biopsy as part of their diagnostic workup for possible mitochondrial disease.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sevofluraneDuring 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. | Drug | slow induction with sevoflurane |
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.
1 secondary outcome
Use cardiovascular and electrical brain measurements to limit amount of sevoflurane and predict individual sensitivity.
Time frame: during induction
Results and safety
The study was stopped early (reason given: However, no intervention reduced the risk of major morbidity or 1 yr mortality). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danield I Sessler, MD study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sevoflurane in people with Mitochondrial Disease, run by d sessler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: However, no intervention reduced the risk of major morbidity or 1 yr mortality). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure cardiovascular stability and electrical brain activity during slow induction with sevoflurane. (time frame: during induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.