Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT00815893
Status:
UNKNOWN
Last Update Posted:
2009-07-28
First Post:
2008-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-27', 'studyFirstSubmitDate': '2008-12-10', 'studyFirstSubmitQcDate': '2008-12-30', 'lastUpdatePostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'grading scores presenting conditions for nasal intubation', 'timeFrame': 'before and after intubation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Fiberoptic nasal intubation', 'satisfaction'], 'conditions': ['Awake Fiberoptic Nasal Intubation']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the feasibility of dexmedetomidine infusion for oral cancer patients undergoing awake fiberoptic nasal intubation. We hypothesized that a loading dose of intravenous dexmedetomidine before awake fiberoptic nasal intubation for oral cancer patients undergoing general anesthesia will provide adequate sedation and analgesia without respiratory depression and upper airway obstruction.', 'detailedDescription': 'Case number: 60, ASA I-III oral cancer patients with limited mouth opening\n\nPatients will be randomly allocated into three groups, Dex group received dexmedetomidine (1.0 mcg/kg) infusion, Control group received saline, and Propofol group received 1% Propofol administrated usng effect-site TCI.\n\nMain outcome was evaluated by grading scores presenting conditions for nasal intubation, post-intubation and satisfaction.\n\nOther analysed parameters included airway obstruction, hemodynamic changes, treatment for hemodynamics response, consumption time for intubation, amnesia level, and postoperative adverse events. All outcome measurements were classified by scoring systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Head and neck cancer patients with limited mouth opening\n* Undergoing awake fiberoptic nasal intubation for elective surgery\n\nExclusion Criteria:\n\n* a history of severe bradycardia\n* any type of A-V block in EKG\n* heart failure\n* liver cirrhosis\n* thrombocytopenia\n* coagulopathy'}, 'identificationModule': {'nctId': 'NCT00815893', 'briefTitle': 'The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation', 'orgStudyIdInfo': {'id': 'KMUHIRB-96-09-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 dex group', 'description': 'received dexmedetomidine (1.0 mcg/kg) infusion', 'interventionNames': ['Drug: dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2 control group', 'description': 'received 0.9% saline', 'interventionNames': ['Drug: Normal Saline 0.9%']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 Propofol group', 'description': 'received 1% propofol using effect-site TCI(Base Primea, Fresenius, France)', 'interventionNames': ['Drug: propofol 1%']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex 100microg/ml'], 'description': 'dexmedetomidine 1.0 mcg/kg infusion for 10minutes', 'armGroupLabels': ['1 dex group']}, {'name': 'Normal Saline 0.9%', 'type': 'DRUG', 'otherNames': ['saline 0.9% Nacl'], 'description': '0.9% Normal Saline 0.25ml/kg infusion for 10minues', 'armGroupLabels': ['2 control group']}, {'name': 'propofol 1%', 'type': 'DRUG', 'otherNames': ['propofol'], 'description': 'Propofol: The initial target = 3 μg/ml. The TCI is adjusted by 0.5μg/ml according to patient comfort during the procedure.\n\nThe Orchestra® Base Primea(Fresenius, Brezins, France) offers a Target Controlled Infusion (TCI) target controlled infusion.', 'armGroupLabels': ['3 Propofol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Koung-Shing Chu, Master', 'role': 'CONTACT', 'email': 'cks0708@ms.kmuh.org.tw', 'phone': '886-7-3121101', 'phoneExt': '7035'}], 'facility': 'Kaohsiung Medical University Chung-Ho Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Koung-Shing Chu, Master', 'role': 'CONTACT', 'email': 'cks0708@ms.kmuh.org.tw', 'phone': '886-7-3121101', 'phoneExt': '7035'}, {'name': 'Cheng-Jing Tsai', 'role': 'CONTACT', 'email': 't8501107@yahoo.com.tw', 'phone': '886-7-3121131', 'phoneExt': '7033'}], 'overallOfficials': [{'name': 'Koung-Shing Chu, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kaohsiung Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Koung-Shing Chu', 'oldOrganization': 'Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Hospital'}}}}