Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 6:18 PM
Study NCT ID:
NCT01234194
Status:
COMPLETED
Last Update Posted:
2010-11-04
First Post:
2010-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Composite Variability Index and Propofol Remifentanil Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-03', 'studyFirstSubmitDate': '2010-11-03', 'studyFirstSubmitQcDate': '2010-11-03', 'lastUpdatePostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Composite Variability Index', 'Bispectral Index', 'Electromyography', 'Nociception', 'Pain'], 'conditions': ['Measure of Nociception']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if the new Composite Variability Index (CVI) is capable of detecting changing effect compartment concentrations of remifentanil. In addition, it is planed to detect if the change in CVI in response to a standardized painful stimulus is dose-dependent.', 'detailedDescription': 'On the day of surgery, patients receive anesthesia by propofol infusion. As soon as the patient is unresponsive und unconscious (BIS 40-60) and a steady state is achieved, a standardized painful stimulus is applied by electrical stimulation of the ulnar nerve (tetanic stimulation \\[70 mA\\], 30 seconds, 50 Hz) in group 1. Thereafter remifentanil is infused to an effect compartment concentration target of 1 ng/ml. The standardized stimulus is applied again as the remifentanil target is reached. This procedure is repeated with remifentanil targets of 2 ng/ml and 3ng/ml. In group 2 remifentanil is targeted to effect compartment concentrations of 3 ng/ml followed by 2,1, and 0 ng/ml.\n\nAfter measuring the effect of the last painful stimulus the patient is intubated for surgery. Throughout the study the Composite Variability Index and standard monitoring is recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing surgical procedure in general anesthesia\n\nExclusion Criteria:\n\n* Pregnancy, drug abuse, cardiac arrhythmia, obesity'}, 'identificationModule': {'nctId': 'NCT01234194', 'briefTitle': 'Composite Variability Index and Propofol Remifentanil Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Changes in the Composite Variability Index in Response to Different Remifentanil Concentrations and Standardized Painful Stimuli.', 'orgStudyIdInfo': {'id': 'CVI_2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'interventionNames': ['Drug: rising remifentanil concentrations']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'interventionNames': ['Drug: falling remifentanil concentrations']}], 'interventions': [{'name': 'rising remifentanil concentrations', 'type': 'DRUG', 'description': 'remifentanil effect-compartment concentrations 0,1,2,3 ng/ml', 'armGroupLabels': ['Group 1']}, {'name': 'falling remifentanil concentrations', 'type': 'DRUG', 'description': 'remifentanil effect-compartment concentrations 3, 2, 1, 0 ng/ml', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53115', 'city': 'Bonn', 'country': 'Germany', 'facility': 'University of Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'overallOfficials': [{'name': 'Richard K Ellerkmann, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bonn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Richard Klaus Ellerkmann / M.D.', 'oldOrganization': 'University of Bonn'}}}}