Anesthesia in Patients With Mitochondrial Disease

The University of Texas System (UT)

Status: Terminated

Conditions: Mitochondrial Diseases

Treatments: Drug: Dexmedetomidine; Drug: Propofol; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02053766

HSC-MS-13-0600

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 1 day to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 3 patient groups

Sevoflurane

Active Comparator group

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.

Treatment:

Drug: Sevoflurane

Dexmedetomidine (Precedex®)

Active Comparator group

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.

Treatment:

Drug: Dexmedetomidine

Propofol

Active Comparator group

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.

Treatment:

Drug: Propofol