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
  Purpose

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 Intervention
Desflurane Levels
Other: Desflurane Levels

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Measure Blood Levels of Desflurane in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • The primary endpoint will simply be the successful measurement of desflurane in human blood. [ Time Frame: During one operation. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 18, 2007
Last Updated: September 14, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Desflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014