Anesthetic Effects in Mitochondrial Disease

NCT01001585 | Terminated

• 1 other identifier: 06-644
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Summary. At the present, the investigators do not have the perfect anesthetic for mitochondrial patients. When possible, consideration should be given to the use of local anesthetics in small amounts. When a general anesthetic is necessary, they each carry significant risks and have been associated with poor outcomes. At present it is not possible to eliminate one group as less safe than others. What is clear is that these patients must be monitored more closely than other patients. The advent of the bispectral index (BIS) monitor may allow us to monitor their depth of anesthesia more closely and thus expose these patients only to the minimum amount of drug necessary to carry out the surgical procedure. Purpose. The investigators hypothesize that specific mitochondrial diseases, in particular those that decrease complex I function, make certain children hypersensitive to volatile anesthetics. These same patients may be at increased risk for adverse outcomes following general anesthesia. The specific aims of this application are:

1. 1.Determine which molecular defects in mitochondrial function lead to alter sensitivity to the VA sevoflurane.
2. 2.Establish the relative safety of sevoflurane in treatment of patients with mitochondrial disease.

Conditions

Mitochondrial Disease

Keywords

mitochondrial disease; sevoflurane; mitochondrial disease and sevoflurane sensitivity

Outcome Measures

Primary Outcomes (1)

• Measure cardiovascular stability and electrical brain activity during slow induction with sevoflurane.

  The investigators plan to monitor patients with mitochondrial disease using expanded measures of cardiovascular stability and measurements of brain electrical activity while slowly inducing general anesthesia. The investigators will use those measurements to limit the amount of anesthetic these patients receive in an attempt to minimize their risk.

  during induction

Secondary Outcomes (1)

• Use cardiovascular and electrical brain measurements to limit amount of sevoflurane and predict individual sensitivity.

  during induction

Study Arms (1)

slow induction with sevoflurane

EXPERIMENTAL

Only children with a BIS greater than 95 prior to inhalation of sevoflurane will be included in the study. Inductions will be done using a tight fitting mask with continuous monitoring of end tidal gas concentrations. During induction, concentration of inspired sevoflurane will begin at .5%, and slowly increased by 0.5% every two minutes, until a Bispectral Index (BIS) of 60 or less is reached. Inspired sevoflurane will be increased only after end tidal concentration of sevoflurane is constant for at least one minute. Each induction (except for the patients requiring very low doses of sevoflurane) will take approximately 10 minutes.

Drug: sevoflurane

Interventions

sevoflurane DRUG

During induction, concentration of inspired sevoflurane will begin at .5%, and slowly increased by 0.5% every two minutes, until a Bispectral Index (BIS) of 60 or less is reached, which will take approximately 10 minutes.

slow induction with sevoflurane

Eligibility Criteria

• Age: 12 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients presenting to the operating room for muscle biopsy as part of their diagnostic workup for possible mitochondrial disease.

You may not qualify if:

• Patients more than 16 years of age.
• Patients with concurrent acute infectious disease.
• Patients not tolerating a slow induction for emotional reasons.
• Initial BIS measurement of less than 95.
• Documented pulmonary disease.

Sponsors & Collaborators

• d sessler: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Mitochondrial Diseases

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Danield I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 26, 2009
• Study Start: September 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

US (1)