Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-31 @ 12:26 PM
Study NCT ID:
NCT01185535
Status:
UNKNOWN
Last Update Posted:
2010-08-20
First Post:
2010-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-19', 'studyFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation condition score during awake intubation period', 'timeFrame': 'one years', 'description': 'Intubating condition score (Jaw relaxation; Laryngoscopy insertion; Vocal cord position; Coughing; Limb movement; Cuff response)'}], 'secondaryOutcomes': [{'measure': 'Stress factor during intubation period', 'timeFrame': 'one year', 'description': 'Blood samples were drawn to measure the serum cortisol and insulin concentration.'}, {'measure': 'Life signs during intubation period', 'timeFrame': 'one year', 'description': 'The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded.'}, {'measure': 'The complications during intubation period', 'timeFrame': 'one year', 'description': 'The complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['topical anesthesia', 'tracheal intubation', 'difficult airway'], 'conditions': ['Difficult Airway']}, 'referencesModule': {'references': [{'pmid': '22340331', 'type': 'DERIVED', 'citation': 'Jiang H, Miao HS, Jin SQ, Chen LH, Tian JL. A pilot study of the effect of pressure-driven lidocaine spray on airway topical anesthesia for conscious sedation intubation. Chin Med J (Engl). 2011 Dec;124(23):3997-4001.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/sites/entrez', 'label': 'PUMED'}]}, 'descriptionModule': {'briefSummary': "As reported, about 0.43% patients can not be intubated unevenly because of difficult airway and 30% of the total death of anesthesia due to failed intubation. The difficult airway will disturb the clinical treatment and even threaten the patients' life. But the present methods for tracheal intubation during awake intubation can not provided ideal intubation condition. In this study, the investigators will perform topical anesthesia with the nebulized 2% lidocaine at 10L/min oxygen flow rate, and the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam,propofol, and remifentanil. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure stress factor during intubation period.Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation. The investigators aim is to evaluate the effect of topical anesthesia with lidocaine nebulized by 10L/min oxygen flow rate during awake tracheal intubation.", 'detailedDescription': "90 adult patients for elective surgery under general anesthesia, aged 18-60 years old, Mallampti Ⅰ-Ⅱ class, , were randomly allocated to receive topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times(each group n=30). Before topical anesthesia, the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam (0.03mg/kg), propofol (2mg/kg/h) and remifentanil (0.05μg/kg/min). Ten minutes after sedation, topical anesthesia was performed with the nebulized 2% lidocaine at 10L/min oxygen flow rate, meantime patients were told to breathe deeply. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure the serum cortisol and insulin concentration during intubation period. Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18-60 years old with Mallampti Ⅰ-Ⅱ class\n\nExclusion Criteria:\n\n* Patients who have allergic reaction to the drugs used during anesthesia\n* Patients who have a history of gastro-esophageal regurgitation, or with full stomach\n* Patients with abnormality of cardiopulmonary function, renal and liver function\n* Patients with abnormality of endocrine function\n* Patients with increased intracranial pressure or epilepsy'}, 'identificationModule': {'nctId': 'NCT01185535', 'briefTitle': 'Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation', 'orgStudyIdInfo': {'id': '20081110362101197410300047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2 times topical anesthesia for glottis', 'interventionNames': ['Procedure: times of topical anesthesia for glottis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 times topical anesthesia for glottis', 'interventionNames': ['Procedure: times of topical anesthesia for glottis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4 times topical anesthesia for glottis', 'interventionNames': ['Procedure: times of topical anesthesia for glottis']}], 'interventions': [{'name': 'times of topical anesthesia for glottis', 'type': 'PROCEDURE', 'otherNames': ['topical anesthesia'], 'description': 'topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times', 'armGroupLabels': ['2 times topical anesthesia for glottis', '3 times topical anesthesia for glottis', '4 times topical anesthesia for glottis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510655', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'lab of The Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jin s qing, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Guangdong Science Committee', 'oldOrganization': 'Guangdong Science Committee'}}}}