Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT03805568
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2019-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Postoperative Sore Throat After Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-13', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-13', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of postoperative sore throat at rest', 'timeFrame': '6 hours after surgery', 'description': '0=none; 1=occur'}, {'measure': 'incidence of postoperative sore throat at swallowing', 'timeFrame': '6 hours after surgery', 'description': '0=none; 1=occur'}, {'measure': 'severity of postoperative sore throat at rest', 'timeFrame': '6 hours after surgery', 'description': '4-point scale (0=none; 1=mild; 2=moderate; 3=severe)'}, {'measure': 'severity of postoperative sore throat at swallowing', 'timeFrame': '6 hours after surgery', 'description': '4-point scale (0=none; 1=mild; 2=moderate; 3=severe)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative sore throat', 'dexmedetomidine', 'remifentanil', 'thyroidectomy'], 'conditions': ['Post Operative Sore Throat']}, 'descriptionModule': {'briefSummary': 'This study was performed to compare the effect on of a postoperative sore throat between dexmedetomidine and remifentanil in patients undergoing thyroidectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who scheduled primary thyroidectomy were enrolled and their physical status was American Society of Anesthesiologists (ASA) class 1 or 2\n\nExclusion Criteria:\n\n* Patients with respiratory tract disease, previous head, and neck surgery, preexisting steroid or non-steroidal anti-inflammatory drug use, and known or suspected difficult airway'}, 'identificationModule': {'nctId': 'NCT03805568', 'briefTitle': 'A Postoperative Sore Throat After Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Yeungnam University College of Medicine'}, 'officialTitle': 'The Effect of Dexmedetomidine and Remifentanil on the Postoperative Sore Throat After Thyroidectomy', 'orgStudyIdInfo': {'id': 'YUMC 2017-03-037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine infusion group', 'description': 'dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery', 'interventionNames': ['Drug: dexmedetomidine infusion group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'remifentanil infusion group', 'description': 'remifentanil of 4 ng/ml during induction, followed by remifentanil infusion (1.5\\~2.5 ng/ml) during the surgery', 'interventionNames': ['Drug: remifentanil infusion group']}], 'interventions': [{'name': 'dexmedetomidine infusion group', 'type': 'DRUG', 'description': 'dexmedetomidine as anaesthetic adjuvant', 'armGroupLabels': ['dexmedetomidine infusion group']}, {'name': 'remifentanil infusion group', 'type': 'DRUG', 'description': 'remifentanil as anaesthetic adjuvant', 'armGroupLabels': ['remifentanil infusion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41944', 'city': 'Daegu', 'state': 'Korea (the Republic Of)', 'country': 'South Korea', 'facility': 'Eun kyung Choi', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeungnam University College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eun Kyung Choi', 'investigatorAffiliation': 'Yeungnam University College of Medicine'}}}}