Clinical trial NCT02053766: Anesthesia in Patients With Mitochondrial Disease
Official title: Anesthesia in Patients With Mitochondrial Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mitochondrial Diseases
Keywords: Mitochondrial Diseases
Sevoflurane
Dexmedetomidine (Precedex®)
Propofol
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event
timeFrame: Up to 48 hours post anesthesia.
Secondary outcomes:
measure: Blood Glucose Level
timeFrame: Baseline
measure: Blood Glucose Level
timeFrame: 24 hours post-operative
measure: Serum pH
timeFrame: Baseline
measure: Serum pH
timeFrame: 24 hours post-operative
measure: Serum Bicarbonate
timeFrame: Baseline
measure: Serum Bicarbonate
timeFrame: 24 hours post-operative
measure: Serum Lactate
timeFrame: Baseline
measure: Serum Lactate
timeFrame: 24 hours post-operative
measure: Serum Pyruvate
timeFrame: Baseline
measure: Serum Pyruvate
timeFrame: 24 hours post-operative
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Maria Matuszczak, MD
role: PRINCIPAL_INVESTIGATOR
References: