Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-25 @ 9:02 AM
Study NCT ID:
NCT03817359
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2019-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '84 patients scheduled for breast cancer surgery were randomly allocated to receive TIVA with propofol and remifentanil separately by two TCI pump (Separate group) or with remifentanil-propofol mixture by single TCI pump (Mix group), all TCI concentration adjustments during operation were based on BIS and ANI monitor.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2019-01-19', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of TCI device adjustments', 'timeFrame': 'during procedure', 'description': 'Total times of TCI pump adjustment'}], 'secondaryOutcomes': [{'measure': 'Mean blood pressure', 'timeFrame': 'at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes', 'description': 'measured by non-invasive blood pressure cuff'}, {'measure': 'Heart rate', 'timeFrame': 'at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes', 'description': 'recorded by ECG and pulse oximetry'}, {'measure': 'Patient satisfaction', 'timeFrame': 'the 1 day after operation', 'description': 'Rating of satisfaction by questionnaire'}, {'measure': 'postoperative analgesia rescue', 'timeFrame': 'An average of 30 minutes after arriving at PACU', 'description': 'Analgesics use during PACU stay'}, {'measure': 'Total dose of remifentanil', 'timeFrame': 'At the end of surgery', 'description': 'total consumption of remifentanil during procedure'}, {'measure': 'Total dose of propofol', 'timeFrame': 'At the end of surgery', 'description': 'total consumption of propofol during procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['propofol', 'remifentanil', 'total intravenous anesthesia', 'breast surgery'], 'conditions': ['Anesthetics', 'Remifentanil', 'Propofol']}, 'referencesModule': {'references': [{'pmid': '30286006', 'type': 'RESULT', 'citation': 'Bedocs P, Evers DL, Buckenmaier CC 3rd. Predosing Chemical Stability of Admixtures of Propofol, Ketamine, Fentanyl, and Remifentanil. Anesth Analg. 2019 Jul;129(1):e13-e15. doi: 10.1213/ANE.0000000000003772.'}, {'pmid': '15500495', 'type': 'RESULT', 'citation': 'Berkenbosch JW, Graff GR, Stark JM, Ner Z, Tobias JD. Use of a remifentanil-propofol mixture for pediatric flexible fiberoptic bronchoscopy sedation. Paediatr Anaesth. 2004 Nov;14(11):941-6. doi: 10.1111/j.1460-9592.2004.01355.x.'}, {'pmid': '10825339', 'type': 'RESULT', 'citation': 'Stewart JT, Warren FW, Maddox FC, Viswanathan K, Fox JL. The stability of remifentanil hydrochloride and propofol mixtures in polypropylene syringes and polyvinylchloride bags at 22 degrees-24 degrees C. Anesth Analg. 2000 Jun;90(6):1450-1. doi: 10.1097/00000539-200006000-00037.'}]}, 'descriptionModule': {'briefSummary': 'Co-administration of propofol and remifentanil is considered to be an ideal total intravenous anesthesia technique, which is widely used in induction and maintenance of general anesthesia. Remifentanil and propofol can be mixed in polypropylene syringes for one hour with a remaining concentration of 91% in small concentrations of remifentanil. However, delivery of remifentanil-propofol mixture by target-controlled infusion(TCI) for general anesthesia in surgical procedure has not been described. Breast cancer surgery ( including modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure for patients with breast cancer with one-hour duration in our hospital. This pilot study was to examine the merit of remifentanil-propofol mixture as a GA regimen for breast cancer surgery.', 'detailedDescription': 'Previous studies has described the feasibility and safety of remifentanil-propofol mixture use in sedation of pediatric patients undergoing magnetic resonance imaging or flexible fiberoptic bronchoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA II or III\n* age more than 18 years\n* scheduled for breast cancer surgery under general anesthesia.\n\nExclusion Criteria:\n\n* previously allergic to propofol or remifentanil\n* combining other surgical procedure leading to extended operative time'}, 'identificationModule': {'nctId': 'NCT03817359', 'briefTitle': 'Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Use of a Remifentanil-propofol Mixture in Patients With Breast Cancer Undergoing Breast Cancer Surgery: a Prospective Pilot Study', 'orgStudyIdInfo': {'id': '2-107-05-079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mix infusion using single TCI pump', 'description': 'participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion', 'interventionNames': ['Combination Product: Remifentanil-propofol mixture']}, {'type': 'NO_INTERVENTION', 'label': 'Separate infusion using two TCI pumps', 'description': 'participants receive total intravenous anesthesia with remifentanil and propofol separately by two TCI pumps infusion'}], 'interventions': [{'name': 'Remifentanil-propofol mixture', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump in intervention group. All TCI target concentration adjustments or extra bolus of propofol or remifentanil during operation were based on BIS and ANI monitor.', 'armGroupLabels': ['Mix infusion using single TCI pump']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Zhi-Fu Wu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Tri-Service General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident physician', 'investigatorFullName': 'Meng-Fu Lai', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}