Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-06 @ 12:27 AM
Study NCT ID:
NCT01760018
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2012-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-17', 'studyFirstSubmitDate': '2012-12-31', 'studyFirstSubmitQcDate': '2013-01-02', 'lastUpdatePostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QoR-40 score', 'timeFrame': 'at 24 hours later after surgery', 'description': 'QoR-40 score is going to be measured at preoperative period, 24 hours, and 48 hours later after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['desflurane, total intravenous anesthesia, QoR-40'], 'conditions': ['Thyroid Operation Under General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '10740540', 'type': 'BACKGROUND', 'citation': 'Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.'}, {'pmid': '25500679', 'type': 'DERIVED', 'citation': 'Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. However, there have not been studies comparing the quality of recovery from the different methods of general anesthesia. In this study, the investigators compare the functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40 questionnaire.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who are undergoing thyroid operation belong to ASA class 1 or 2\n\nExclusion Criteria:\n\n* patients who are belongs to ASA class 3 or more,\n* patients who have underlying complicated cardiovascular or psychological disease.'}, 'identificationModule': {'nctId': 'NCT01760018', 'briefTitle': 'Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2012-0748'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desflurane group', 'interventionNames': ['Drug: desflurane group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TIVA(total intravenous anesthesia) group', 'interventionNames': ['Drug: TIVA group']}], 'interventions': [{'name': 'desflurane group', 'type': 'DRUG', 'description': 'anesthesia is maintained with desflurane and remifentanil (Desflurane group)', 'armGroupLabels': ['Desflurane group']}, {'name': 'TIVA group', 'type': 'DRUG', 'description': 'anesthesia is maintained with fresofol and remifentanil (TIVA group).', 'armGroupLabels': ['TIVA(total intravenous anesthesia) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}