Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2026-01-14 @ 2:24 PM
Study NCT ID:
NCT02275702
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between pain with visual analog scale and lung function through spirometry test with forced expiratory volume at one second (FEV1) and diffusion capacity (DLCO)', 'timeFrame': 'During the hospital stay and 1 year later'}, {'measure': 'Total opioid dose consumption in each group', 'timeFrame': 'During the hospital stay and 1 year later'}, {'measure': 'Side-effect of dexamethasone in the stress response to surgery', 'timeFrame': 'During the hospital stay and 1 year later'}], 'primaryOutcomes': [{'measure': 'The primary outcome of this study will be postoperative quality of recovery measured by postoperative quality of recovery score 40 (QoR-40) global score.', 'timeFrame': 'During the hospital stay and 1 year later'}], 'secondaryOutcomes': [{'measure': 'Time of analgesia between the final intercostal nerve block and the first patient-controlled analgesia (PCA) request;', 'timeFrame': 'During the hospital stay and 1 year later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexamethasone', 'Quality of recovery questionnaire', 'QoR-40', 'Lung cancer', 'Video-assisted thoracoscopic'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small dose of IV dexamethasone during induction anesthesia in association to pre and postoperative intercostal nerve block, improves quality of recovery of thoracoscopic lung resection patients.', 'detailedDescription': 'This is a study composed by 2 groups of 50 patients undergoing VATS for lung cancer. All subjets will receive intraoperative intercostal nerve block with a maximum dose of 2 mg/kg of bupivacaine with epinephrine 1:200.000 at the beginning and at the end of procedure.\n\nThe control group will receive a bolus dose of dexamethasone (0.1 mg/kg) and the placebo group saline solution. The study drug or placebo will be administered at the time of anesthetic induction (approximately 30 minutes before surgical incision). Patients will be evaluated daily with the quality of recovery questionary, visual analogue pain and portable spirometry. And, the patients will have pulmonary lung function assessed by portable spirometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* resectable stage I and II lung cancer patients submitted to VATS\n* american society of anesthesiology Classification (ASA) I or II\n\nExclusion Criteria:\n\n* chronic pain;\n* chronic analgesic consumption;\n* severe renal or liver disease;\n* endocrine or mental diseases;\n* poorly controlled diabetes;\n* allergy to bupivacaine;\n* previous thoracotomy;\n* systemic use of corticosteroids;\n* morbid obesity;\n* poor French comprehension precluding completion of the QoR-40 questionnaire;\n* patient refusal.'}, 'identificationModule': {'nctId': 'NCT02275702', 'acronym': 'APV', 'briefTitle': 'Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients', 'orgStudyIdInfo': {'id': 'APV-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1', 'description': 'saline solution IV, bolus', 'interventionNames': ['Drug: Saline solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': '0,1mg/kg systemic dose of dexamethasone, bolus', 'interventionNames': ['Drug: Dexamethasone IV']}], 'interventions': [{'name': 'Dexamethasone IV', 'type': 'DRUG', 'otherNames': ['Decadron'], 'description': 'It will be administered at the induction of the anesthesia', 'armGroupLabels': ['Group 2']}, {'name': 'Saline solution', 'type': 'DRUG', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1v 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1V3H8', 'city': 'Québec', 'country': 'Canada', 'facility': 'IUCPQ', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Paula A. Ugalde, Medicin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Universitaire de Cardilogie et Pneumologie de Québec, IUCPQ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}