Anesthesia in Patients With Mitochondrial Disease

Mitochondrial Diseases Clinical Trial

Official title:

Anesthesia in Patients With Mitochondrial Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02053766
• Other study ID #: HSC-MS-13-0600
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2014
• Est. completion date: September 2022

Study information

• Verified date: September 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: Stephanie Maldonado
• Phone: 713-828-4291
• Email: Stephanie.Maldonado[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitochondrial Diseases

Intervention

Drug:
• Sevoflurane
Sevoflurane up to 8% will be administered to study subjects
• Dexmedetomidine
Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.
• Propofol
Propofol up to 50 mcg/ kg/min will be administered to study subjects.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 48 hours post anesthesia.