Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT01878656
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2013-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D000077335', 'term': 'Desflurane'}], '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'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nbjhwa@naver.com', 'phone': '82-2-6299-2579', 'title': 'Dr. Chong Wha Baek', 'organization': 'Chung-Ang University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sevoflurane', 'description': 'administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia\n\nSevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.', 'otherNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Desflurane', 'description': 'administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia\n\nDesflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.', 'otherNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Incidence of Emergence Agitation Using Four-point Categorical Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sevoflurane', 'description': 'administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia\n\nSevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.'}, {'id': 'OG001', 'title': 'Desflurane', 'description': 'administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia\n\nDesflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.', 'description': 'The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Time to Extubation', 'timeFrame': 'Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.', 'description': "We will evaluate the time from gas discontinuation to extubation. We will conduct an extubation when participants can show responses such as eye opening or nodding one's head to our verbal commands.", 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postoperative Pain', 'timeFrame': 'Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.', 'description': 'The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sense of Suffocation', 'timeFrame': 'Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.', 'description': 'The outcomes assessor will evaluate the sense of suffocation using a numeric rating scale(NRS). (0 = no sense of suffocation, 10 = unimaginably severe sense of suffocation)', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sevoflurane', 'description': 'administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia\n\nSevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.'}, {'id': 'FG001', 'title': 'Desflurane', 'description': 'administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia\n\nDesflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sevoflurane', 'description': 'administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia\n\nSevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.'}, {'id': 'BG001', 'title': 'Desflurane', 'description': 'administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia\n\nDesflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '27'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '27'}, {'value': '23', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-04', 'studyFirstSubmitDate': '2013-06-12', 'resultsFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-04', 'studyFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': 'Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.', 'description': 'The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)'}, {'measure': 'Sense of Suffocation', 'timeFrame': 'Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.', 'description': 'The outcomes assessor will evaluate the sense of suffocation using a numeric rating scale(NRS). (0 = no sense of suffocation, 10 = unimaginably severe sense of suffocation)'}], 'primaryOutcomes': [{'measure': 'The Incidence of Emergence Agitation Using Four-point Categorical Scale', 'timeFrame': 'Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.', 'description': 'The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.'}], 'secondaryOutcomes': [{'measure': 'The Time to Extubation', 'timeFrame': 'Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.', 'description': "We will evaluate the time from gas discontinuation to extubation. We will conduct an extubation when participants can show responses such as eye opening or nodding one's head to our verbal commands."}]}, 'conditionsModule': {'conditions': ['Emergence Agitation']}, 'descriptionModule': {'briefSummary': 'Emergence agitation is a major concern in patients undergoing orthognathic surgery. The patients may experience the sense of suffocation during emergence due to nasotracheal intubation and orofacial edema. Postoperative pain is also associated with emergence agitation. Although there is a lot of studies about emergence agitation in children, there is a few in adults, furthermore, no data about comparison of emergence agitation between sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to compare the incidence and severity of emergence agitation between sevoflurane and desflurane anesthesia in adults after orthognathic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients\n* patients scheduled for orthognathic surgery\n\nExclusion Criteria:\n\n* severe cardiopulmonary disease\n* psychological disease\n* patients who cannot understand Korean'}, 'identificationModule': {'nctId': 'NCT01878656', 'briefTitle': 'Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}, 'orgStudyIdInfo': {'id': 'Chung-Ang University Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane', 'description': 'administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Desflurane', 'description': 'administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia', 'interventionNames': ['Drug: Desflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Desflurane', 'type': 'DRUG', 'description': 'The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.', 'armGroupLabels': ['Desflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-755', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chongwha Baek, M.D., Ph.D.', 'investigatorFullName': 'Chongwha Baek', 'investigatorAffiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}}}}