Study Results
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View full resultsBasic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2014-01-10
2020-10-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Sevoflurane
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.
Sevoflurane
Sevoflurane up to 8% will be administered to study subjects
Dexmedetomidine (Precedex®)
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.
Dexmedetomidine
Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.
Propofol
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.
Propofol
Propofol up to 50 mcg/ kg/min will be administered to study subjects.
Interventions
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Sevoflurane
Sevoflurane up to 8% will be administered to study subjects
Dexmedetomidine
Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.
Propofol
Propofol up to 50 mcg/ kg/min will be administered to study subjects.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
1 Day
17 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Maria Matuszczak
◦Professor of Anesthesiology-Clinical
Principal Investigators
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Maria Matuszczak, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-13-0600
Identifier Type: -
Identifier Source: org_study_id
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