Trial record 3 of 88 for:    "myoclonic epilepsy myopathy sensory ataxia" OR "Mitochondrial Diseases"

Anesthesia in Patients With Mitochondrial Disease

This study is currently recruiting participants.
Verified February 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02053766
First received: January 31, 2014
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient.


Condition Intervention
Mitochondrial Diseases
Drug: Sevoflurane
Drug: Dexmedetomidine
Drug: Propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Anesthesia in Patients With Mitochondrial Disease

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

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. [ Time Frame: Up to 48 hours post anesthesia. ] [ Designated as safety issue: No ]

    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:

    1. 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.
    2. 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.


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Sevoflurane
Sevoflurane up to 8% will be administered to study subjects
Other Name: Ultane
Active Comparator: 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.
Drug: Dexmedetomidine
Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.
Other Name: Precedex
Active Comparator: 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.
Drug: Propofol
Propofol up to 50 mcg/ kg/min will be administered to study subjects.
Other Name: Diprivan

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02053766

Contacts
Contact: Rahmat Adejumo, MBBS, MPH 7138847164 ext 4 Rahmat.B.Adejumo@uth.tmc.edu

Locations
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Adejumo, MBBS, MPH    713-500-7147    Rahmat.B.Adejumo@uth.tmc.edu   
Principal Investigator: Maria Matuszczak, MD         
Sub-Investigator: Mary Kay Koenig, MD         
Sub-Investigator: Jael Carbajal, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Maria Matuszczak, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02053766     History of Changes
Other Study ID Numbers: HSC-MS-13-0600
Study First Received: January 31, 2014
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Mitochondrial Diseases
Sevoflurane
Dexmedetomidine (Precedex®)
Propofol

Additional relevant MeSH terms:
Mitochondrial Diseases
Metabolic Diseases
Anesthetics
Propofol
Sevoflurane
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014