NCT02053766

Anesthesia in Patients With Mitochondrial Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitochondrial Diseases

Interventions

Type	Name	Description
DRUG	Sevoflurane	Sevoflurane up to 8% will be administered to study subjects
DRUG	Dexmedetomidine	Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.
DRUG	Propofol	Propofol up to 50 mcg/ kg/min will be administered to study subjects.

Timeline

• Start date: 2014-01-10
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2014-02-04
• Last updated: 2024-08-28
• Results posted: 2024-07-17

Locations

1 site across 1 country: United States