A Pilot Study to Measure Blood Levels of Desflurane in Children
Information source: Children's Hospital of Philadelphia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Desflurane Levels
Intervention: Desflurane Levels (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Children's Hospital of Philadelphia Official(s) and/or principal investigator(s):
Kha Tran, MD, Principal Investigator, Affiliation: Children's Anesthesiology Associates, Ltd.
Overall contact:
Kha Tran, MD, Phone: 267-426-5590, Email: trank@email.chop.edu
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.
Clinical Details
Official title: A Pilot Study to Measure Blood Levels of Desflurane in Children
Study design: Diagnostic, Open Label, Single Group Assignment, Bio-availability Study
Primary outcome: The primary endpoint will simply be the successful measurement of desflurane in human blood.
Secondary outcome: Secondary endpoints will include obtaining similar levels of desflurane across several patients who are have similar levels of end expiratory desflurane.
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.
Eligibility
Minimum age: 1 Year.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Kha Tran, MD, Phone: 267-426-5590, Email: trank@email.chop.edu
The Children's Hospital Of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Kha Tran, MD, Principal Investigator
Additional Information
Starting date: December 2007
Ending date: September 2008
Last updated: December 19, 2007
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