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Anesthesia in Patients With Mitochondrial Disease

Primary Purpose

Mitochondrial Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sevoflurane
Dexmedetomidine
Propofol
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mitochondrial Diseases focused on measuring Mitochondrial Diseases, Sevoflurane, Dexmedetomidine (Precedex®), Propofol

Eligibility Criteria

1 Day - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sevoflurane

Dexmedetomidine (Precedex®)

Propofol

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

The primary outcome 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.
An adverse event (AE) is any untoward medical occurrence in a subject, compared with pre-existing condition that occurs during any phase of the research study. An AE is defined as being independent of assumption of any causality. The following laboratory values and physical findings are to be considered AEs: Laboratory value(s) of blood glucose, serum lactate, serum pyruvate, serum bicarbonate and pH that change from a subject's baseline by greater than 10% and is outside the normal range. Any of the following parameters; feeding difficulties, temperature >100 F, vomiting, nausea, lethargy, change in admission plan and any other change in baseline that are clinically relevant.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2014
Last Updated
September 29, 2020
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02053766
Brief Title
Anesthesia in Patients With Mitochondrial Disease
Official Title
Anesthesia in Patients With Mitochondrial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2014 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitochondrial Diseases
Keywords
Mitochondrial Diseases, Sevoflurane, Dexmedetomidine (Precedex®), Propofol

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dexmedetomidine (Precedex®)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Ultane
Intervention Description
Sevoflurane up to 8% will be administered to study subjects
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Propofol up to 50 mcg/ kg/min will be administered to study subjects.
Primary Outcome Measure Information:
Title
The primary outcome 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.
Description
An adverse event (AE) is any untoward medical occurrence in a subject, compared with pre-existing condition that occurs during any phase of the research study. An AE is defined as being independent of assumption of any causality. The following laboratory values and physical findings are to be considered AEs: Laboratory value(s) of blood glucose, serum lactate, serum pyruvate, serum bicarbonate and pH that change from a subject's baseline by greater than 10% and is outside the normal range. Any of the following parameters; feeding difficulties, temperature >100 F, vomiting, nausea, lethargy, change in admission plan and any other change in baseline that are clinically relevant.
Time Frame
Up to 48 hours post anesthesia.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Maldonado
Phone
713-828-4291
Ext
4
Email
Stephanie.Maldonado@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Matuszczak, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Maldonado
Phone
713-828-4291
Email
Stephanie.Maldonado@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Maria Matuszczak, MD
First Name & Middle Initial & Last Name & Degree
Mary Kay Koenig, MD
First Name & Middle Initial & Last Name & Degree
Jael Carbajal, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Anesthesia in Patients With Mitochondrial Disease

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