Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT06651905
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2024-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-19', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The intubation score', 'timeFrame': 'time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords.Time range of 10 minutes', 'description': 'The intubation conditions score is assessed based on the following criteria:\n\n(i) Vocal movement: 1 = open, 2 = moving, 3 = closing, 4 = closed. (ii) Coughing: 1 = none, 2 = slight, 3 = moderate, 4 = severe. (iii) Limb movement: 1 = none, 2 = slight, 3 = moderate, 4 = severe.\n\nWhere The Intubation conditions score is :\n\nExcellent = 1 when all qualities are excellent. Good = 2 when all qualities are either excellent or good. Poor = 3 when the presence of a single poor quality is noted.'}], 'secondaryOutcomes': [{'measure': 'The degree of comfort', 'timeFrame': 'time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords. Time range of 10 minutes', 'description': 'The comfort score was evaluated using a five-point fiberoptic intubation comfort scale: 1 = no reaction, 2 = slight grimace, 3 = heavy grimace, 4 = verbal objection, and 5 = defensive movement of head and hands.'}, {'measure': 'Degree of airway obstruction', 'timeFrame': 'time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords Time range of 10 minutes', 'description': 'The degree of airway obstruction (1 - absent, 2 - requiring neck extension, 3 - requiring jaw thrust) was noted'}, {'measure': 'Heart rate', 'timeFrame': 'From one minute before intubation to 10 minutes after intubation', 'description': 'Heart rate is recorded at 1-minute intervals until intubation is completed, followed by measurements every two minutes until 10 minutes after intubation.'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'From one minute before intubation till10 minutes after intubation', 'description': 'Mean arterial blood pressure is recorded at 1-minute intervals until intubation is completed, followed by measurements every two minutes until 10 minutes after intubation.'}, {'measure': 'Ramsay sedation score', 'timeFrame': 'From time of injection of Drugs (Dexetodomidine , Lidocaine) to the patient to 10 minutes after intubation', 'description': 'Ramsay sedation score was recorded as follows: 1: Awake, agitated or restless or both; 2: Awake, cooperative, oriented, and tranquil; 3: Awake but responds to commands only; 4: Asleep, with a brisk response to a light glabellar tap or loud auditory stimulus.'}, {'measure': 'Patient satisfaction score', 'timeFrame': 'From the end of the operation to 24 hours postoperative', 'description': 'The patient satisfaction score (1-excellent, 2-good, 3-reasonable, 4-poor) was documented.'}, {'measure': 'Incidence of complications', 'timeFrame': 'From the end of the operation to 24 hours postoperative', 'description': 'Adverse events such as bradycardia, hypotension, nausea, vomiting, pruritus, respiratory depression, O2 desaturation, or any other complications were recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Superior Laryngeal Nerve Block', 'Sedation', 'Dexmedetomidine', 'Awake Fiberoptic Intubation', 'Hemimandibulectomy', 'Anticipated Difficult Airway']}, 'descriptionModule': {'briefSummary': 'This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age range ≥ 18 or ≤60.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) II-III.\n* Body mass index:18.5 to 30 kg/m2.\n* Hemimandibulectomy patients with an anticipated difficult airway \\[El-Ganzouri Risk Index (EGRI)\\>3\\].\n\nExclusion Criteria:\n\n* Patient's refusal.\n* Known allergy to drugs used in the study.\n* Neurological disorders.\n* Advanced liver or kidney disease.\n* Patient with psychiatric disorders.\n* Patient who needs postoperative ICU.\n* Airway distortion and cervical spine movement."}, 'identificationModule': {'nctId': 'NCT06651905', 'briefTitle': 'Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Superior Laryngeal Nerve Block Versus Sedation with Intravenous Dexmedetomidine Infusion for Awake Fiberoptic Intubation of Hemimandibulectomy Patients with an Anticipated Difficult Airway: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MS-484-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine group', 'description': 'Patients were given 0.5 mcg/kg of dexmedetomidine over 10 minutes via a syringe pump, followed by a maintenance dose of 0.2-0.7 mcg/kg/hour until the end of intubation based on Hemodynamics.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Superior laryngeal nerve block group', 'description': 'Patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve.', 'interventionNames': ['Drug: Superior laryngeal nerve block']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Sedation arm'], 'description': 'The patients were given 0.5 mcg /kg dexmedetomidine over 10 min via syringe pump, followed by 0.2-0.7 mcg/kg/hour until the end of intubation according to hemodynamics.', 'armGroupLabels': ['Dexmedetomidine group']}, {'name': 'Superior laryngeal nerve block', 'type': 'DRUG', 'otherNames': ['Nerve Block arm'], 'description': 'The patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve.', 'armGroupLabels': ['Superior laryngeal nerve block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Tarek Abd EL Halim Kaddah, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor'}, {'name': 'Mai M EL Rawas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt', 'investigatorFullName': 'Marwa Zayed', 'investigatorAffiliation': 'Cairo University'}}}}