Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-05 @ 5:46 AM
Study NCT ID:
NCT02208505
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, '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': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-17', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-08-03', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'quality of recovery from anesthesia', 'timeFrame': 'upto 1day after surgery', 'description': 'using Quality of Recovery-40 questionnaire, evaluate the recovery status of patient from general anesthesia'}], 'primaryOutcomes': [{'measure': 'Incidence of coughing during emergence from general anesthesia', 'timeFrame': 'from 5min before extubation to 5min after extubation'}], 'secondaryOutcomes': [{'measure': 'side effect of remifentanil', 'timeFrame': 'up to 1 day after surgery', 'description': 'comparison of the incidence of delayed awakening, post-operative nausea/vomiting, consumption of pain killer'}]}, 'conditionsModule': {'conditions': ['Thyroidectomy']}, 'descriptionModule': {'briefSummary': 'After thyroid surgery, the incidence and severity of coughing is important because it may cause serious complications, such as bleeding in the surgical field, laryngospasm, and cardiovascular disturbance. Several studies have shown that the single-dose of dexmedetomidine is effective for reducing cough and agitation during emergence from general anesthesia.\n\nTo test the hypothesis that single-dose of dexmedetomidine combined with a low-dose remifentanil infusion during emergence from general anaesthesia could reduce coughing as good as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and reduction of side effect of remifentanil using non-inferiority trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thyroid disease undergoing thyroidectomy\n* age 20-65\n* Amerian society of anesthesgiologist class 1 or 2\n\nExclusion Criteria:\n\n* chronic cough\n* difficult intubation\n* liver disease\n* uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT02208505', 'briefTitle': 'Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion During Emergence in Adults After Thyroidectomy: Comparison With High-dose Remifentanil Infusion Alone', 'orgStudyIdInfo': {'id': "3-2013-0192'"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'we administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml).', 'interventionNames': ['Drug: Dexmedetomidine + Remifentanil-low dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanil', 'description': 'we administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone.', 'interventionNames': ['Drug: Remifentanil-high dose']}], 'interventions': [{'name': 'Dexmedetomidine + Remifentanil-low dose', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'single dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Remifentanil-high dose', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': 'maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)', 'armGroupLabels': ['Remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong Soo Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Jeong Soo Lee', 'investigatorAffiliation': 'Yonsei University'}}}}