Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT00577369
Status:
COMPLETED
Last Update Posted:
2009-09-16
First Post:
2007-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Measure Blood Levels of Desflurane in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2007-12-18', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2009-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint will simply be the successful measurement of desflurane in human blood.', 'timeFrame': 'During one operation.'}], 'secondaryOutcomes': [{'measure': 'Secondary endpoints will include obtaining similar levels of desflurane across several patients who are have similar levels of end expiratory desflurane.', 'timeFrame': 'During one operation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arterial line', 'end-expiratory desflurane'], 'conditions': ['Desflurane Levels']}, 'descriptionModule': {'briefSummary': "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).\n\nOur 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.", 'detailedDescription': '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.\n\nHigh 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.\n\nOur 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children between 1 and 18 years old\n2. Weight \\>10 kg\n3. Scheduled for elective surgery\n4. Patient will have an arterial catheter placed as routine care for the surgery\n5. Informed consent (and assent if applicable)\n\nExclusion Criteria:\n\n1. Desflurane not used as part of anesthetic\n2. Preoperative hemoglobin less than 9 mg/dl\n3. Any investigational drug use within 30 days prior to enrollment\n4. Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT00577369', 'briefTitle': 'A Pilot Study to Measure Blood Levels of Desflurane in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'A Pilot Study to Measure Blood Levels of Desflurane in Children', 'orgStudyIdInfo': {'id': '2006-12-5096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': "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.", 'interventionNames': ['Other: Desflurane Levels']}], 'interventions': [{'name': 'Desflurane Levels', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital Of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kha Tran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Anesthesiology Associates, Ltd."}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Anesthesiology Associates, Ltd.", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Kha Tran, MD', 'oldOrganization': "The Children's Hospital of Philadelphia"}}}}