Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT03653494
Status:
UNKNOWN
Last Update Posted:
2018-08-31
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Clinicaltrail of the Effection Which of Phrenic Block Using in Non-intubated Video-assisted Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-04-24', 'releaseDate': '2020-04-10'}], 'estimatedResultsFirstSubmitDate': '2020-04-10'}}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Volunteers and data collectors was masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Put 80 patients divided into group S（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block） and group D（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block）randomly.\n2. Compare the volume of anesthetic drugs between the two groups.\n3. If the date of group S greater than group D，it shows that the effect of anesthetic effect of group D is better than group S.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the volume of anesthetic drugs', 'timeFrame': 'the time of operation， an average of 4 hours', 'description': 'the volume of anesthetic drugs including sevoflurane,propofol and opioids during the operation'}], 'secondaryOutcomes': [{'measure': 'the time to get out of bed after surgery', 'timeFrame': 'two days after surgery', 'description': 'note the time to get out of bed after surgery'}, {'measure': 'the cost of hospitalization', 'timeFrame': 'the time of hospitalization， an average of 7 days', 'description': 'note the the cost of hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-intubated general anaesthesia', 'video-assisted thoracoscopic surgery', 'phrenic block'], 'conditions': ['Phrenic Nerve Paralysis']}, 'descriptionModule': {'briefSummary': 'Putting 80 patients divided into group S（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block） and group D（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block）randomly,compare the volume of anesthetic and the number of increasing anesthetic during operation were compared between the two groups.If the date of group S greater than group D，it shows that the effect of anesthetic effect of group D is better than group S.', 'detailedDescription': '1. Put 80 patients divided into group S（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block） and group D（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block）randomly.\n2. Compare the volume of anesthetic drugs between the two groups.\n3. If the date of group S greater than group D，it shows that the effect of anesthetic effect of group D is better than group S.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient agreed to perform non-intubated video-assisted thoracoscopic surgery, and informed the possibility of intraoperative tracheal intubation or thoracotomy.\n* No conventional anesthesia contraindication, no history of thoracic surgery, good cardiopulmonary function.\n* There is no severe adhesion and calcification in the thoracic cavity, and no artificial pneumothorax is affected.\n* the patient has no serious anxiety or depression.\n* Small surgical trauma, simple steps, short time.\n\nExclusion Criteria:\n\n* Mallampati≥3.\n* BMI≥26 kg/m2.\n* Hemodynamic instability.\n* INR≥1.5.\n* Respiratory infection, persistent cough or airway mucus hypersecretion, high risk of reflux.\n* nervous system disease,such as seizure or brain edema.\n* Extensive pleural adhesions or once chest surgery.\n* PaO2\\<60mmHg or PaCO2\\>50 mmHg.\n* Central hypopnea syndrome.\n* Lung isolation should be used to protect the healthy side of the lung.\n* Complicated operation, large trauma, long time, lack of experience or poor cooperation in the surgical team.\n* Contraindications to local anesthetic.'}, 'identificationModule': {'nctId': 'NCT03653494', 'briefTitle': 'the Clinicaltrail of the Effection Which of Phrenic Block Using in Non-intubated Video-assisted Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': "Shenzhen People's Hospital"}, 'officialTitle': "Department of Anesthesiology in Shenzhen People's Hospital", 'orgStudyIdInfo': {'id': 'daizhongliang-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'phrenic block group', 'description': 'non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block', 'interventionNames': ['Procedure: phrenic block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block', 'interventionNames': ['Procedure: no phrenic block']}], 'interventions': [{'name': 'phrenic block', 'type': 'PROCEDURE', 'description': 'phrenic block by 1% ropivacaine 5ml', 'armGroupLabels': ['phrenic block group']}, {'name': 'no phrenic block', 'type': 'PROCEDURE', 'description': 'no phrenic block', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518020', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'overallOfficials': [{'name': 'Dai Z Liang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': "Shenzhen People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shenzhen People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-04-10', 'type': 'RELEASE'}, {'date': '2020-04-24', 'type': 'RESET'}], 'unpostedResponsibleParty': "Shenzhen People's Hospital"}}}}