Mitochondrial DiseasesNCT02053766
Anesthesia in Patients With Mitochondrial Disease
A study testing Sevoflurane, Dexmedetomidine and Propofol in people with Mitochondrial Diseases, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Mitochondrial Diseases
- What is being tested?
- Sevoflurane, Dexmedetomidine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2014to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must fulfill the following inclusion criteria:
- Subject is informed and given ample opportunity to consider his/her participation and has given his/her written consent.
- Subject is willing and able to comply with all study requirements.
- Subject is between 0 - 17 years of age.
- Subject has been diagnosed with mitochondrial dysfunction based on modified Walker criteria.
- Subject is scheduled to have a non-emergent diagnostic or therapeutic procedure for routine medical care requiring general anesthesia estimated to last at least one hour.
- Subject is classified ASA I - IV
Who cannot join
- Subjects are not permitted to enroll in the study if any of the following criteria are met:
- Subject is older than 17 years
- Subject is pregnant
- Subject is a nursing female and
- Subject has participated in the same study within 48 hours
- Subject is allergic or has had any adverse effect to any of the study agents in the past
- Anesthesia time is less than one hour
- Subject is classified ASA V
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient.
Read the detailed description
Study subjects undergoing a routine medical care non-emergent procedure will be randomized into three different groups to receive one of the following anesthetic agents; Sevoflurane, Propofol or Dexmedetomidine.
The primary outcome of this pilot study is to evaluate and compare the incidence of adverse events in mitochondrial patients undergoing a diagnostic or therapeutic procedure up to 48 hours post anesthesia. The secondary outcome is to compare the metabolic derangements between three study groups by comparing changes in blood sugar, serum pH, serum bicarbonate, serum lactate and serum pyruvate levels before, during and after anesthesia in the groups.
- Conditions
- Mitochondrial Diseases
- Being tested
- Sevoflurane, Dexmedetomidine, Propofol
- Keywords
- Mitochondrial Diseases, Sevoflurane, Dexmedetomidine (Precedex®), Propofol
- 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
Also called Ultane
Sevoflurane up to 8% will be administered to study subjects
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.
PropofolDrug
Also called Diprivan
Propofol up to 50 mcg/ kg/min will be administered to study subjects.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure. Receives: Drug: Sevoflurane |
| Dexmedetomidine (Precedex®) | Active comparator | These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure. Receives: Drug: Dexmedetomidine |
| Propofol | Active comparator | These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced an Adverse Event
Measured: Up to 48 hours post anesthesia.
Secondary outcomes (10)
Blood Glucose Level
Measured: Baseline
Blood Glucose Level
Measured: 24 hours post-operative
Serum pH
The pH scale measures how acidic of alkaline a substance is and ranges from 0 to 14, where 7 is neutral, 14 is the most alkaline and 0 is the most acidic.
Measured: Baseline
Serum pH
The pH scale measures how acidic of alkaline a substance is and ranges from 0 to 14, where 7 is neutral, 14 is the most alkaline and 0 is the most acidic.
Measured: 24 hours post-operative
Serum Bicarbonate
Measured: Baseline
Serum Bicarbonate
Measured: 24 hours post-operative
Serum Lactate
Measured: Baseline
Serum Lactate
Measured: 24 hours post-operative
Serum Pyruvate
Measured: Baseline
Serum Pyruvate
Measured: 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study start10 Jan 2014
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: due to covid-19 we were not on track with enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mitochondrial DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Matuszczak, The University of Texas Health Science Center, Houston
- Investigators
- Maria Matuszczak, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053766
- Sponsor's protocol ID
- HSC-MS-13-0600
- Status last verified
- Aug 2024
- First submitted
- 31 Jan 2014
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia in Patients With Mitochondrial Disease
- ClinicalTrials.gov ID
- NCT02053766
- Acronym / sponsor ID
- HSC-MS-13-0600
- Conditions
- Mitochondrial Diseases
- Keywords
- Mitochondrial Diseases, Sevoflurane, Dexmedetomidine (Precedex®), Propofol
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to covid-19 we were not on track with enrollment rate
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Posted 17 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient.
Detailed description
Study subjects undergoing a routine medical care non-emergent procedure will be randomized into three different groups to receive one of the following anesthetic agents; Sevoflurane, Propofol or Dexmedetomidine.
The primary outcome of this pilot study is to evaluate and compare the incidence of adverse events in mitochondrial patients undergoing a diagnostic or therapeutic procedure up to 48 hours post anesthesia. The secondary outcome is to compare the metabolic derangements between three study groups by comparing changes in blood sugar, serum pH, serum bicarbonate, serum lactate and serum pyruvate levels before, during and after anesthesia in the groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: SevofluraneIn the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure. |
| Dexmedetomidine (Precedex®) | Active comparator | Drug: DexmedetomidineThese subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure. |
| Propofol | Active comparator | Drug: PropofolThese subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure. |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects must fulfill the following inclusion criteria:
- Subject is informed and given ample opportunity to consider his/her participation and has given his/her written consent.
- Subject is willing and able to comply with all study requirements.
- Subject is between 0 - 17 years of age.
- Subject has been diagnosed with mitochondrial dysfunction based on modified Walker criteria.
Key exclusion criteria (8 listed)
- Subjects are not permitted to enroll in the study if any of the following criteria are met:
- Subject is older than 17 years
- Subject is pregnant
- Subject is a nursing female and
- Subject has participated in the same study within 48 hours
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 |
|---|---|---|
| SevofluraneAlso: UltaneSevoflurane up to 8% will be administered to study subjects | Drug | Sevoflurane |
| DexmedetomidineAlso: PrecedexDexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects. | Drug | Dexmedetomidine (Precedex®) |
| PropofolAlso: DiprivanPropofol up to 50 mcg/ kg/min will be administered to study subjects. | Drug | Propofol |
Primary outcome
Number of Participants Who Experienced an Adverse Event
Time frame: Up to 48 hours post anesthesia.
10 secondary outcomes
Blood Glucose Level
Time frame: Baseline
Blood Glucose Level
Time frame: 24 hours post-operative
Serum pH
Time frame: Baseline
Serum pH
Time frame: 24 hours post-operative
Serum Bicarbonate
Time frame: Baseline
Serum Bicarbonate
Time frame: 24 hours post-operative
Serum Lactate
Time frame: Baseline
Serum Lactate
Time frame: 24 hours post-operative
Serum Pyruvate
Time frame: Baseline
Serum Pyruvate
Time frame: 24 hours post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Mitochondrial Diseases
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
The NIH MINI Study: Metabolism, Infection, and Immunity in Inborn Errors of Metabolism
Oxidative Phosphorylation Deficiencies, Electron Transport Chain Disorders, Mitochondrial
RecruitingPhase 2
An Open-Label Study of CTI-1601 in Subjects With Friedreich's Ataxia
Friedreich Ataxia
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
Not yet recruitingPhase 3
Efficacy and Safety of Modafinil to Treat Fatigue in People With Mitochondrial Disease.
Mitochondrial Disease
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.
Maria Matuszczak, MD principal investigator
The University of Texas Health Science Center, Houston
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, Dexmedetomidine and Propofol in people with Mitochondrial Diseases, run by The University of Texas Health Science Center, Houston 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 7 inclusion and 8 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 28 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experienced an Adverse Event (time frame: Up to 48 hours post anesthesia.). 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 28 Aug 2024.