Trial Outcomes & Findings for Anesthesia in Patients With Mitochondrial Disease (NCT NCT02053766)
NCT ID: NCT02053766
Last Updated: 2024-08-28
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Up to 48 hours post anesthesia.
Results posted on
2024-08-28
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sevoflurane
n=6 Participants
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®)
n=7 Participants
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
n=6 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.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
6.5 years
STANDARD_DEVIATION 4.22 • n=6 Participants
|
6.57 years
STANDARD_DEVIATION 4.15 • n=7 Participants
|
4.33 years
STANDARD_DEVIATION 2.33 • n=6 Participants
|
5.84 years
STANDARD_DEVIATION 3.67 • n=19 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
16 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
7 participants
n=7 Participants
|
6 participants
n=6 Participants
|
19 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hours post anesthesia.Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=7 Participants
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
n=6 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.
|
Sevoflurane
n=6 Participants
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
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event
|
2 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=6 Participants
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
n=5 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.
|
Sevoflurane
n=6 Participants
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
|
|---|---|---|---|
|
Blood Glucose Level
|
88.66 milligrams per decilitre
Standard Deviation 15.29
|
89.20 milligrams per decilitre
Standard Deviation 4.76
|
83.66 milligrams per decilitre
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 24 hours post-operativePopulation: 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.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=3 Participants
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
n=2 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.
|
Sevoflurane
n=4 Participants
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
|
|---|---|---|---|
|
Blood Glucose Level
|
87 milligrams per decilitre
Standard Deviation 7
|
81.50 milligrams per decilitre
Standard Deviation 13.43
|
93.75 milligrams per decilitre
Standard Deviation 16.50
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm.
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.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=6 Participants
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
n=5 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.
|
Sevoflurane
n=6 Participants
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
|
|---|---|---|---|
|
Serum pH
|
7.39 score on a scale
Standard Deviation 7.37
|
7.36 score on a scale
Standard Deviation 0.05
|
7.37 score on a scale
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: 24 hours post-operativePopulation: 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.
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.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=3 Participants
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
n=1 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.
|
Sevoflurane
n=2 Participants
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
|
|---|---|---|---|
|
Serum pH
|
7.36 score on a scale
Standard Deviation 0.05
|
7.40 score on a scale
Standard Deviation NA
Standard Deviation not available since only 1 participant was analyzed for the assessment
|
7.32 score on a scale
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=6 Participants
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
n=5 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.
|
Sevoflurane
n=6 Participants
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
|
|---|---|---|---|
|
Serum Bicarbonate
|
25.50 millimoles per liter
Standard Deviation 1.91
|
24.04 millimoles per liter
Standard Deviation 3.66
|
25.23 millimoles per liter
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: 24 hours post-operativePopulation: 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.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=3 Participants
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
n=1 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.
|
Sevoflurane
n=2 Participants
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
|
|---|---|---|---|
|
Serum Bicarbonate
|
24.33 millimoles per liter
Standard Deviation 4.16
|
20 millimoles per liter
Standard Deviation NA
Standard Deviation not available since only 1 participant was analyzed for the assessment
|
26.5 millimoles per liter
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=6 Participants
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
n=5 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.
|
Sevoflurane
n=6 Participants
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
|
|---|---|---|---|
|
Serum Lactate
|
1.28 millimoles per liter
Standard Deviation 0.44
|
0.82 millimoles per liter
Standard Deviation 0.25
|
1.36 millimoles per liter
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: 24 hours post-operativePopulation: 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.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=4 Participants
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
n=3 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.
|
Sevoflurane
n=4 Participants
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
|
|---|---|---|---|
|
Serum Lactate
|
2.76 millimoles per liter
Standard Deviation 0.47
|
1.15 millimoles per liter
Standard Deviation 0.36
|
2.50 millimoles per liter
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=4 Participants
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
n=3 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.
|
Sevoflurane
n=4 Participants
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
|
|---|---|---|---|
|
Serum Pyruvate
|
0.72 milligrams per decilitre
Standard Deviation 0.47
|
1.06 milligrams per decilitre
Standard Deviation 0.36
|
1.03 milligrams per decilitre
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 24 hours post-operativePopulation: 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.
Outcome measures
| Measure |
Dexmedetomidine (Precedex®)
n=2 Participants
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
n=1 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.
|
Sevoflurane
n=3 Participants
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
|
|---|---|---|---|
|
Serum Pyruvate
|
1.34 milligrams per decilitre
Standard Deviation 0.85
|
1.32 milligrams per decilitre
Standard Deviation NA
Standard Deviation not available since only 1 participant was analyzed for the assessment
|
1.42 milligrams per decilitre
Standard Deviation 0.69
|
Adverse Events
Sevoflurane
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dexmedetomidine (Precedex®)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Propofol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sevoflurane
n=6 participants at risk
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®)
n=7 participants at risk
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
n=6 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Vomiting
|
0.00%
0/6 • 48 hours
|
14.3%
1/7 • 48 hours
|
33.3%
2/6 • 48 hours
|
|
General disorders
Fever
|
33.3%
2/6 • 48 hours
|
14.3%
1/7 • 48 hours
|
0.00%
0/6 • 48 hours
|
|
General disorders
lower back pain
|
0.00%
0/6 • 48 hours
|
14.3%
1/7 • 48 hours
|
0.00%
0/6 • 48 hours
|
|
General disorders
lethargy
|
0.00%
0/6 • 48 hours
|
28.6%
2/7 • 48 hours
|
16.7%
1/6 • 48 hours
|
|
General disorders
Nausea
|
0.00%
0/6 • 48 hours
|
0.00%
0/7 • 48 hours
|
16.7%
1/6 • 48 hours
|
|
General disorders
mood change
|
16.7%
1/6 • 48 hours
|
14.3%
1/7 • 48 hours
|
0.00%
0/6 • 48 hours
|
|
General disorders
feeding difficulties
|
16.7%
1/6 • 48 hours
|
0.00%
0/7 • 48 hours
|
16.7%
1/6 • 48 hours
|
|
Cardiac disorders
tachycardia
|
33.3%
2/6 • 48 hours
|
0.00%
0/7 • 48 hours
|
16.7%
1/6 • 48 hours
|
Additional Information
Maria Matuszczak
The University of Texas Health Science Center at Houston
Phone: 713 -500-5075
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place