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Propofol for Mitochondrial Disease

N/A
Waitlist Available
Led By Maria Matuszczak, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours post anesthesia.
Awards & highlights

Study Summary

This trial will study whether anesthesia affects mitochondrial function in patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 hours post anesthesia.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours post anesthesia. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measure of this study is to evaluate and compare the incidence of adverse events in mitochondrial patients undergoing a diagnostic or therapeutic procedure between the three drug groups.

Trial Design

3Treatment groups
Active Control
Group I: PropofolActive Control1 Intervention
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.
Group II: SevofluraneActive Control1 Intervention
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.
Group III: Dexmedetomidine (Precedex®)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,964 Total Patients Enrolled
Maria Matuszczak, MDPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Anesthesia in Patients With Mitochondrial Disease
Maria Matuszczak 2014. "Anesthesia in Patients With Mitochondrial Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02053766.
All > Mitochondrial Disease
~5 spots leftby Apr 2025
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