Anesthesia in Patients With Mitochondrial Disease

NCT02053766 | Terminated Results

• 1 other identifier: HSC-MS-13-0600
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mitochondrial Diseases

Keywords

Mitochondrial Diseases; Sevoflurane; Dexmedetomidine (Precedex®); Propofol

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced an Adverse Event

  Up to 48 hours post anesthesia.

Secondary Outcomes (10)

• Blood Glucose Level

  Baseline

• Blood Glucose Level

  24 hours post-operative

• Serum pH

  Baseline

• Serum pH

  24 hours post-operative

• Serum Bicarbonate

  Baseline

Study Arms (3)

Sevoflurane

ACTIVE COMPARATOR

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

Dexmedetomidine (Precedex®)

ACTIVE COMPARATOR

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

Propofol

ACTIVE COMPARATOR

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

Interventions

Sevoflurane DRUG

Sevoflurane up to 8% will be administered to study subjects

Also known as: Ultane

Sevoflurane

Dexmedetomidine DRUG

Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.

Also known as: Precedex

Dexmedetomidine (Precedex®)

Propofol DRUG

Propofol up to 50 mcg/ kg/min will be administered to study subjects.

Also known as: Diprivan

Propofol

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Mitochondrial Diseases

Interventions

Sevoflurane; Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Maria Matuszczak
• Organization: The University of Texas Health Science Center at Houston

maria.matuszczak@uth.tmc.edu

713 -500-5075

Study Officials

• Maria Matuszczak, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ◦Professor of Anesthesiology-Clinical

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: January 10, 2014
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 28, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)