A Pilot Study to Measure Blood Levels of Desflurane in Children

This study has been completed.
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00577369
First received: December 18, 2007
Last updated: September 14, 2009
Last verified: September 2009

December 18, 2007
September 14, 2009
December 2007
June 2008   (final data collection date for primary outcome measure)
The primary endpoint will simply be the successful measurement of desflurane in human blood. [ Time Frame: During one operation. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00577369 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pilot Study to Measure Blood Levels of Desflurane in Children
A Pilot Study to Measure Blood Levels of Desflurane in Children

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.

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.

Interventional
Not Provided
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Desflurane Levels
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.
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.
Intervention: Other: Desflurane Levels
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577369
2006-12-5096
No
Kha Tran, MD, The Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Principal Investigator: Kha Tran, MD Children's Anesthesiology Associates, Ltd.
Children's Hospital of Philadelphia
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP