Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-30 @ 4:52 PM
Study NCT ID:
NCT05253404
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2022-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant will going general anesthesia'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic', 'timeFrame': '30 minutes', 'description': 'Blood pressure including systolic, diastolic and mean arterial pressure and heart rate during extubation'}, {'measure': 'Pulmonary complications', 'timeFrame': '24 hours', 'description': 'Rate of Participants with Cough, Bucking, Laryngospasm, Aspiration, Desaturation(SpO2%\\< 90%) and Need airway assist device(Nasal or oral airway)'}, {'measure': 'Partial pressure of carbon dioxide in arterial blood', 'timeFrame': '20 mins', 'description': 'Partial pressure of carbon dioxide in arterial blood five minutes before and after extubation'}], 'secondaryOutcomes': [{'measure': 'Re-do surgery', 'timeFrame': '24 hours', 'description': 'Number of Participants with Re-do neurosurgery within 24hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extubation', 'Laryngeal mask', 'Craniotomies'], 'conditions': ['Complications, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '27212749', 'type': 'BACKGROUND', 'citation': 'Suppiah RK, Rajan S, Paul J, Kumar L. Respiratory and hemodynamic outcomes following exchange extubation with laryngeal mask airway as compared to traditional awake extubation. Anesth Essays Res. 2016 May-Aug;10(2):212-7. doi: 10.4103/0259-1162.174469.'}, {'pmid': '9709138', 'type': 'BACKGROUND', 'citation': 'Koga K, Asai T, Vaughan RS, Latto IP. Respiratory complications associated with tracheal extubation. Timing of tracheal extubation and use of the laryngeal mask during emergence from anaesthesia. Anaesthesia. 1998 Jun;53(6):540-4. doi: 10.1046/j.1365-2044.1998.00397.x.'}, {'pmid': '33510786', 'type': 'BACKGROUND', 'citation': 'Wong TH, Weber G, Abramowicz AE. Smooth Extubation and Smooth Emergence Techniques: A Narrative Review. Anesthesiol Res Pract. 2021 Jan 15;2021:8883257. doi: 10.1155/2021/8883257. eCollection 2021.'}, {'pmid': '33121440', 'type': 'BACKGROUND', 'citation': 'Juang J, Cordoba M, Ciaramella A, Xiao M, Goldfarb J, Bayter JE, Macias AA. Incidence of airway complications associated with deep extubation in adults. BMC Anesthesiol. 2020 Oct 29;20(1):274. doi: 10.1186/s12871-020-01191-8.'}, {'pmid': '36650435', 'type': 'DERIVED', 'citation': 'Wei CF, Chung YT. Laryngeal mask airway facilitates a safe and smooth emergence from anesthesia in patients undergoing craniotomy: a prospective randomized controlled study. BMC Anesthesiol. 2023 Jan 17;23(1):29. doi: 10.1186/s12871-023-01972-x.'}]}, 'descriptionModule': {'briefSummary': 'Stabilizing hemodynamic and reducing pulmonary complications during extubation with switching endotracheal tube to laryngeal mask in craniotomies', 'detailedDescription': 'recruit ASA: 1-3, 20-65 years old undergoing neurosurgery under general anesthesia Excluded 1.Decline to participated 2.Difficult airway 3.Body Mass Index \\>30 4. Pregnant woman 5.Nothing Per Os \\<8hrs(case number:80).\n\nGeneral anesthesia Induction: 0.15-0.2 mg/kg cisatracurium or 0.6-1.2mg rocuronium , 1.5-2 mg/kg propofol, 1-2 mcg/kg Fentanyl. Endotracheal tube 6.5-7.5mm. Maintenance with sevoflurane 2- 3% FiO2:100%. Optimal muscle tension monitor. When surgery done, sevoflurane at 2.63-2.97%\n\nThen randomly assigned two group Anesthesia group(control group) : Removed endotracheal tube at sevoflurane at 2-3% Switching group (intervention group): Intervention with endotracheal tube to laryngeal mask, and removing laryngeal mask at sevoflurane: 0.4MAC'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA: 1-3, 20-65 years old undergoing craniotomies under general anesthesia\n\nExclusion Criteria:\n\n* Decline to participated\n* Difficult airway\n* Body Mass Index \\>30\n* Pregnant woman\n* Nothing Per Os \\<8hrs'}, 'identificationModule': {'nctId': 'NCT05253404', 'briefTitle': 'Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '202102115A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Anesthesia remove endotracheal tube', 'description': 'When craniotomy surgery was done, inhalation anesthestic sevoflurane level will control at MAC 2-3%, at the same time we perform suction secretions in endotracheal tube and oral cavity and give neostigmine 0.05-0.07 mg/kg and glycopyrrolate 0.01mg/kg via intravascular catheter. Removing endotracheal tube when spontaneously generating tidal volume of \\>4ml/kg, EtCO2\\<45mmHg, Train of four ratio \\>70-90%.'}, {'type': 'EXPERIMENTAL', 'label': 'Switching endotracheal tube to laryngeal mask', 'description': 'When craniotomy surgery was done, inhalation anesthestic sevoflurane level will control at 2.63%-2.97%, we perform suction secretions in endotracheal tube and oral cavity, then switching endotracheal tube to laryngeal mask. Then we discontinue inhalation anesthestic sevoflurane and support oxygen at the rate of 6L/min. At the same time, give neostigmine 0.05-0.07 mg/kg and glycopyrrolate 0.01mg/kg via intravascular catheter. Removing endotracheal tube when sevofulrane at MAC 0.4, spontaneously generating tidal volume of \\>4ml/kg, EtCO2\\<45mmHg, Train of four ratio \\>70-90%.', 'interventionNames': ['Device: Ambu® AuraOnce™ Disposable Laryngeal Mask']}], 'interventions': [{'name': 'Ambu® AuraOnce™ Disposable Laryngeal Mask', 'type': 'DEVICE', 'description': 'Switching endotracheal tube to laryngeal mask at sevoflurane 2.63-2.97%, Removing endotracheal tube when spontaneously generating tidal volume of \\>4ml/kg, EtCO2\\<45mmHg, Train of four ratio \\>70-90%.', 'armGroupLabels': ['Switching endotracheal tube to laryngeal mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Wei Cheng-Fong', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'overallOfficials': [{'name': 'Yung-Tai Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'Cheng-Fong Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wei. Cheng-Fong', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}