Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT01308320
Status:
COMPLETED
Last Update Posted:
2011-03-04
First Post:
2011-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-03', 'studyFirstSubmitDate': '2011-03-03', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thyroid Neoplasm']}, 'referencesModule': {'references': [{'pmid': '9637637', 'type': 'BACKGROUND', 'citation': 'Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. doi: 10.1097/00000542-199806000-00007.'}, {'pmid': '7725888', 'type': 'BACKGROUND', 'citation': 'Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9. doi: 10.1111/j.1399-6576.1995.tb05597.x.'}]}, 'descriptionModule': {'briefSummary': 'Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general anaesthesia through binding to its receptors in the brainstem. However, it has not been proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the relationship between fentanyl doses and cough suppression during emergence from sevoflurane anaesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm.\n* ASA I-II.\n* 20-59 years old.\n* female only.\n\nExclusion Criteria:\n\n* signs of difficult intubation.\n* risks for perioperative pulmonary aspiration.\n* history of chronic respiratory disease.\n* recent upper respiratory track infection.\n* previous and recent smoking history'}, 'identificationModule': {'nctId': 'NCT01308320', 'briefTitle': 'Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia', 'orgStudyIdInfo': {'id': '4-2009-0111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'control group', 'interventionNames': ['Drug: saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'F1 group', 'description': 'F1 group : fentanyl 1 mcg/kg', 'interventionNames': ['Drug: fentanyl citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'F1.5 group', 'description': 'F1.5 group : fentanyl 1.5 mcg/kg', 'interventionNames': ['Drug: fentanyl citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'F2 group', 'description': 'F2 group : fentanyl 2 mcg/kg', 'interventionNames': ['Drug: fentanyl citrate']}], 'interventions': [{'name': 'fentanyl citrate', 'type': 'DRUG', 'description': 'According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.', 'armGroupLabels': ['F1 group', 'F1.5 group', 'F2 group']}, {'name': 'saline', 'type': 'DRUG', 'description': 'According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jeong-Rim Lee / Assistant Professor', 'oldOrganization': 'Severance Hospital, Department of Anesthesiology and Pain Medicine in Yonsei University College of Medicine'}}}}