Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT01103193
Status:
TERMINATED
Last Update Posted:
2012-05-08
First Post:
2010-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nitrous Oxide - Sevoflurane-Remifentanil Interaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Need of change to the protocol. As the Principal Investigator has left the University Hospital Ghent end 2010, the change of protocol was never submitted.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-07', 'studyFirstSubmitDate': '2010-03-19', 'studyFirstSubmitQcDate': '2010-04-12', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the pharmacodynamic interaction between nitrous oxide, sevoflurane and remifentanil', 'timeFrame': 'Every 12 minutes during induction and maintenance of anesthesia', 'description': 'The interaction is studied on response surfaces including several clinical endpoints: the observer assessment of alertness and sedation scale, the heart rate, pulse oximetry, blood pressure, EEG and the derived parameters from it: spectral entropy and BIS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASA class I/II patients, with surgery under general anesthesia'], 'conditions': ['ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'patients are allocated to one of the two study groups.\n\nIn both groups a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol. In the second group remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.\n\nDuring the study, at predefined times, we will assess different levels of sedation (OAA/S score) and the reaction on tetanic stimulation of the ulnar nerve, insertion of a laryngeal mask airway and laryngoscopy. In addition heart rate, SpO2 and capnography will be recorded continuously and non invasive bloodpressure will be recorded using a 1 minute interval time. Spectral entropy and BIS derived from the frontal EEG will be used to monitor clinical cerebral drug effect.\n\nThe null hypothesis is that remifentanil lowers the concentration of sevoflurane dissolved in a mixture of 60% nitrous oxide and 40% oxygen to (1) tolerate a specific stimulation and to (2) obtain a certain electroencephalographic parameter value and vice versa. Additionally the results of this study will be compared with a former interaction study of the same study group that did not involve nitrous oxide, in order to depict the shift in the response surface evoked by nitrous oxide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesia class I and II patients\n* aged 18-60 years\n* scheduled for surgery under general anesthesia.\n\nExclusion Criteria:\n\n* Weight less than 70% or more than 130% of ideal body weight\n* neurological disorder\n* diseases involving the cardiovascular system, pulmonary disease, gastric diseases, endocrinological diseases\n* recent use of psycho-active medication, including alcohol'}, 'identificationModule': {'nctId': 'NCT01103193', 'briefTitle': 'Nitrous Oxide - Sevoflurane-Remifentanil Interaction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Nitrous Oxide - Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance.', 'orgStudyIdInfo': {'id': '2009/493'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'remifentanil injected', 'description': 'a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol.', 'interventionNames': ['Drug: remifentanil injected']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sevoflurane in step up concentration', 'description': 'a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.', 'interventionNames': ['Drug: sevoflurane in step up concentration']}], 'interventions': [{'name': 'remifentanil injected', 'type': 'DRUG', 'description': 'mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol.', 'armGroupLabels': ['remifentanil injected']}, {'name': 'sevoflurane in step up concentration', 'type': 'DRUG', 'description': 'of 60% nitrous oxide and 40% oxygen is administered through a face mask.remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.', 'armGroupLabels': ['sevoflurane in step up concentration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Hugo Vereecke, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}