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due to covid-19 we were not on track with enrollment rate
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This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Sevoflurane up to 8% will be administered to study subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | Up to 48 hours post anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Level | Baseline | |
| Blood Glucose Level | 24 hours post-operative | |
| Serum pH |
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Inclusion Criteria:
Exclusion Criteria:
Subjects are not permitted to enroll in the study if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Matuszczak, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced an Adverse Event | Posted | Count of Participants | Participants | Up to 48 hours post anesthesia. |
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Matuszczak | The University of Texas Health Science Center at Houston | 713 -500-5075 | maria.matuszczak@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2018 | May 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D028361 | Mitochondrial Diseases |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Dexmedetomidine | Drug | Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects. |
|
|
| Propofol | Drug | Propofol up to 50 mcg/ kg/min will be administered to study subjects. |
|
|
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.
| 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. | 24 hours post-operative |
| Serum Bicarbonate | Baseline |
| Serum Bicarbonate | 24 hours post-operative |
| Serum Lactate | Baseline |
| Serum Lactate | 24 hours post-operative |
| Serum Pyruvate | Baseline |
| Serum Pyruvate | 24 hours post-operative |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
| OG002 | 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 |
|
|
| Secondary | Blood Glucose Level | Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm. | Posted | Mean | Standard Deviation | milligrams per decilitre | Baseline |
|
|
|
| Secondary | Blood Glucose Level | Data were not collected for 4 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 4 participants in the Propofol arm. Data were not collected for 2 participants in the Sevoflurane arm. | Posted | Mean | Standard Deviation | milligrams per decilitre | 24 hours post-operative |
|
|
|
| Secondary | 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. | Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | 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. | Data were not collected for 4 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 5 participants in the Propofol arm. Data were not collected for 4 participants in the Sevoflurane arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours post-operative |
|
|
|
| Secondary | Serum Bicarbonate | Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm. | Posted | Mean | Standard Deviation | millimoles per liter | Baseline |
|
|
|
| Secondary | Serum Bicarbonate | Data were not collected for 4 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 5 participants in the Propofol arm. Data were not collected for 4 participants in the Sevoflurane arm. | Posted | Mean | Standard Deviation | millimoles per liter | 24 hours post-operative |
|
|
|
| Secondary | Serum Lactate | Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm. | Posted | Mean | Standard Deviation | millimoles per liter | Baseline |
|
|
|
| Secondary | Serum Lactate | Data were not collected for 3 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 3 participants in the Propofol arm. Data were not collected for 2 participants in the Sevoflurane arm. | Posted | Mean | Standard Deviation | millimoles per liter | 24 hours post-operative |
|
|
|
| Secondary | Serum Pyruvate | Data were not collected for 3 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 3 participants in the Propofol arm. Data were not collected for 2 participants in the Sevoflurane arm. | Posted | Mean | Standard Deviation | milligrams per decilitre | Baseline |
|
|
|
| Secondary | Serum Pyruvate | Data were not collected for 5 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 5 participants in the Propofol arm. Data were not collected for 3 participants in the Sevoflurane arm. | Posted | Mean | Standard Deviation | milligrams per decilitre | 24 hours post-operative |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | 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. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG002 | 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. | 0 | 6 | 0 | 6 | 2 | 6 |
| Fever | General disorders | Systematic Assessment |
|
| lower back pain | General disorders | Systematic Assessment |
|
| lethargy | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| mood change | General disorders | Systematic Assessment |
|
| feeding difficulties | General disorders | Systematic Assessment |
|
| tachycardia | Cardiac disorders | Systematic Assessment |
|
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| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| Male |
|