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A Pilot Study to Measure Blood Levels of Desflurane in Children

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ClinicalTrials.gov Identifier: NCT00577369
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : September 16, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

In this feasibility study we will collect blood from indwelling arterial catheters in up to 20 patients undergoing non-emergent surgery with desflurane anesthesia at Children's Hospital of Philadelphia. Desflurane levels will be determined by high pressure liquid chromatography (HPLC).

Our eventual goal is to quantify fetal levels of desflurane in umbilical cord blood during fetal surgery. We propose a pilot study to assess the ability of our assay to measure desflurane in human blood.


Condition or disease Intervention/treatment
Desflurane Levels Other: Desflurane Levels

Detailed Description:

Fetal surgery is an evolving field. Some previously fatal diseases can be surgically corrected before birth. Animal models of the procedures have been carefully translated to humans, but less is known about anesthetic techniques. In children, inadequate anesthesia results in greater stress responses as shown by cardiovascular, neuro-endocrine, and metabolic changes. These stress responses have been associated with poorer outcomes. One of the major goals of anesthesia for these procedures is to attenuate this stress response. Fetuses get intramuscular opioids before their incision, and the mother is given high doses of volatile anesthetic (desflurane) with the assumption that whatever amount of desflurane crosses the placenta adequately anesthetizes the fetus. No studies have quantified the fetal levels of desflurane.

High pressure liquid chromatography (HPLC) has been used to measure levels of volatile anesthetic in various tissues. Measurement of desflurane has been challenging because of its higher boiling point (23.5 °C at one atmosphere pressure) when compared to older volatile anesthetics such as sevoflurane (boiling point 58.6 °C) and isoflurane (boiling point 48.5 °C). With techniques in cold rooms and using ice for sample transport, investigators have successfully measured desflurane levels in blood and brain tissue of mice.

Our eventual goal is to quantify fetal levels of desflurane in umbilical cord blood during fetal surgery, but we first propose a pilot study to assess and refine the ability of our assay to measure desflurane in human blood.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Measure Blood Levels of Desflurane in Children
Study Start Date : December 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Desflurane
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
The subject's participation will take place over one surgical procedure. It will begin with the first blood collection and end with either the second blood draw or the end of the procedure.
Other: Desflurane Levels
The subject's participation will take place over one surgical procedure. It will begin with the first blood collection and end with either the second blood draw or the end of the procedure.


Outcome Measures

Primary Outcome Measures :
  1. The primary endpoint will simply be the successful measurement of desflurane in human blood. [ Time Frame: During one operation. ]

Secondary Outcome Measures :
  1. Secondary endpoints will include obtaining similar levels of desflurane across several patients who are have similar levels of end expiratory desflurane. [ Time Frame: During one operation. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children between 1 and 18 years old
  2. Weight >10 kg
  3. Scheduled for elective surgery
  4. Patient will have an arterial catheter placed as routine care for the surgery
  5. Informed consent (and assent if applicable)

Exclusion Criteria:

  1. Desflurane not used as part of anesthetic
  2. Preoperative hemoglobin less than 9 mg/dl
  3. Any investigational drug use within 30 days prior to enrollment
  4. Pregnant or lactating females
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577369


Locations
United States, Pennsylvania
The Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Investigators
Principal Investigator: Kha Tran, MD Children's Anesthesiology Associates, Ltd.
More Information

Responsible Party: Kha Tran, MD, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00577369     History of Changes
Other Study ID Numbers: 2006-12-5096
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009

Keywords provided by Children's Hospital of Philadelphia:
arterial line
end-expiratory desflurane

Additional relevant MeSH terms:
Desflurane
Isoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs