Clinical Trial: Anesthesia in Patients With Mitochondrial Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Anesthesia in Patients With Mitochondrial Disease

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

Detailed Summary:

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.


Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: 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. [ Time Frame: Up to 48 hours post anesthesia. ]

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:

  1. 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.
  2. 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: January 31, 2014
Date Started: January 2014
Date Completion: December 2018
Last Updated: April 29, 2017
Last Verified: April 2017