Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-05 @ 5:46 AM
Study NCT ID:
NCT01774305
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2012-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ration99@yuhs.ac', 'phone': '+82-2-2019-6092', 'title': 'Dr. Jeongsoo Lee', 'organization': 'Yonsei Univ. Health System, Gangnam Severance Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 hours', 'description': 'prolonged intubation more than 3 hrs, due to changed surgical plan.', 'eventGroups': [{'id': 'EG000', 'title': 'Dexmedetomidine', 'description': 'We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.', 'otherNumAtRisk': 71, 'otherNumAffected': 1, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline', 'description': 'We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.', 'otherNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'prolonged intubation', 'notes': '1 patient in Dex group was intubated more than 3 hrs due to changed surgical plan.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1.4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Coughing Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from the time of eye opening to 5 min after extubation', 'description': 'The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Emergence Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine', 'description': 'We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.'}], 'classes': [{'categories': [{'measurements': [{'value': '492', 'spread': '176', 'groupId': 'OG000'}, {'value': '355', 'spread': '151', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)', 'description': 'The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.', 'unitOfMeasure': 'sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexmedetomidine', 'description': 'We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.'}, {'id': 'FG001', 'title': 'Saline', 'description': 'We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'recruitment period : Sep.2012. \\~ Jan. 2013 types of location : medical clinic.', 'preAssignmentDetails': 'there was no specific pre-assignment details.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexmedetomidine', 'description': 'We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.'}, {'id': 'BG001', 'title': 'Saline', 'description': 'We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.3', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '45.6', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'smoking', 'classes': [{'title': 'smoking', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'non-smoking', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'It has been known that smoking history is related to coughing.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'A patient in group Dexmedetomidine was not completed this study due to changed surgery plan. (Intubated time prolonged more than 3 hours)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-13', 'studyFirstSubmitDate': '2012-12-22', 'resultsFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2013-01-19', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-17', 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coughing Grade', 'timeFrame': 'from the time of eye opening to 5 min after extubation', 'description': 'The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).'}], 'secondaryOutcomes': [{'measure': 'Emergence Time', 'timeFrame': 'from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)', 'description': 'The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.'}]}, 'conditionsModule': {'conditions': ['Coughing']}, 'referencesModule': {'references': [{'pmid': '25523837', 'type': 'DERIVED', 'citation': 'Lee JS, Choi SH, Kang YR, Kim Y, Shim YH. Efficacy of a single dose of dexmedetomidine for cough suppression during anesthetic emergence: a randomized controlled trial. Can J Anaesth. 2015 Apr;62(4):392-8. doi: 10.1007/s12630-014-0295-6. Epub 2014 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'Coughing during emergence from general anaesthesia may lead to dangerous effects including laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during emergence from anaesthesia.\n\nIn this study, we investigated whether intravenous single-dose dexmedetomidine at the end of surgery reduces coughing during extubation after thyroidectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status 1 or 2 patients patients scheduled for thyroidectomy\n\nExclusion Criteria:\n\n* Severe cardiovascular disease history of motion sickness active status of upper respiratory infection allergy to dexmedetomidine patients who cannot understand Korean'}, 'identificationModule': {'nctId': 'NCT01774305', 'briefTitle': 'Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy', 'orgStudyIdInfo': {'id': '3-2012-0142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine', 'description': 'We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': 'We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Yonsei university college of medicine', 'investigatorFullName': 'Jeong Soo Lee', 'investigatorAffiliation': 'Yonsei University'}}}}