Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-13 @ 8:32 AM
Study NCT ID:
NCT02712528
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2016-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to reach BIS > 80', 'timeFrame': '1 minute', 'description': 'Time to reach BIS \\> 80 after surgery'}], 'secondaryOutcomes': [{'measure': 'Extubation time', 'timeFrame': '1 minute', 'description': 'Time to perform extubation after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bispectral index', 'extubation', 'recovery', 'remifentanil'], 'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': "Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac surgery include patient's recovery in cognitive function from the postoperative residual effects of anesthetics, such as opioids and sedatives, administered during intraoperative period. Therefore employing anesthetic regimens which can provide earlier recovery in cognitive function would be beneficial in facilitating fast-track cardiac surgery with earlier postoperative extubation and discharge from the intensive care unit (ICU).\n\nPrevious investigations suggested efficacy of BIS in evaluating the degree of postoperative hypnosis in the ICU.\n\nThe present study compares the time for reaching BIS greater than 80 after using 2 different anesthesia regimens for cardiac surgery, remifentanil-based regimen and sevoflurane-sufentanil balanced regimen.\n\nAnalyzing the changes immediately after cardiac surgery would be useful to determine the degree of patient's postoperative emergence.\n\nMaterials and Methods:\n\nDuring study period, patients undergoing elective cardiac surgery in Konkuk University Medical Center are randomly assigned to get remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60 (Group R) or sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) balanced regimen in Group S.\n\nAll patients get intravenous patient controlled anesthesia consisting of alfentanyl and ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered during postoperative 2 hours in Group R.\n\nAs a primary objective, inter-group difference in the time for achieving BIS greater than 80 is determined."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing elective coronary artery bypass surgery\n\nExclusion Criteria:\n\n* combined valve surgery\n* preoperative intraaortic balloon pumping\n* preoperative low cardiac output syndrome\n* chronic obstructive pulmonary disease'}, 'identificationModule': {'nctId': 'NCT02712528', 'briefTitle': 'Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Recovery Profiles of Remifentanil-based vs. Sevoflurane-sufentanil Combined Regimen for Cardiac Surgery', 'orgStudyIdInfo': {'id': 'KUH1160080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'remifentanil-based', 'description': 'remifentanil-based regimen consisting of remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60', 'interventionNames': ['Drug: remifentanil-based']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sevoflurane-sufentanil balanced', 'description': 'balanced sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) regimen', 'interventionNames': ['Drug: sevoflurane-sufentanil balanced']}], 'interventions': [{'name': 'remifentanil-based', 'type': 'DRUG', 'armGroupLabels': ['remifentanil-based']}, {'name': 'sevoflurane-sufentanil balanced', 'type': 'DRUG', 'armGroupLabels': ['sevoflurane-sufentanil balanced']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Tae-Yop Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Tae-Yop Kim, MD PhD', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}