Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 5:05 AM
Study NCT ID:
NCT00440960
Status:
COMPLETED
Last Update Posted:
2007-02-27
First Post:
2007-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic
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': 'D015742', 'term': 'Propofol'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D015760', 'term': 'Alfentanil'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'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': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'lastUpdateSubmitDate': '2007-02-26', 'studyFirstSubmitDate': '2007-02-26', 'studyFirstSubmitQcDate': '2007-02-26', 'lastUpdatePostDateStruct': {'date': '2007-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-27', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['alfentanil', 'anesthesia', 'bronchoscopy', 'lidocaine', 'midazolam', 'propofol.'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '7842773', 'type': 'BACKGROUND', 'citation': 'Pue CA, Pacht ER. Complications of fiberoptic bronchoscopy at a university hospital. Chest. 1995 Feb;107(2):430-2. doi: 10.1378/chest.107.2.430.'}, {'pmid': '11506101', 'type': 'RESULT', 'citation': 'Barr J, Egan TD, Sandoval NF, Zomorodi K, Cohane C, Gambus PL, Shafer SL. Propofol dosing regimens for ICU sedation based upon an integrated pharmacokinetic-pharmacodynamic model. Anesthesiology. 2001 Aug;95(2):324-33. doi: 10.1097/00000542-200108000-00011.'}, {'pmid': '16211735', 'type': 'RESULT', 'citation': 'Schaeuble J, Heidegger T, Gerig HJ, Ulrich B, Schnider TW. Comparision of etomidate and propofol for fibreoptic intubation as part of an airway management algorithm:a prospective, randomizes, double-blind study. Eur J Anaesthesiol. 2005 Oct;22(10):762-7. doi: 10.1017/s0265021505001262.'}, {'pmid': '2245677', 'type': 'RESULT', 'citation': 'Amitai Y, Zylber-Katz E, Avital A, Zangen D, Noviski N. Serum lidocaine concentrations in children during bronchoscopy with topical anesthesia. Chest. 1990 Dec;98(6):1370-3. doi: 10.1378/chest.98.6.1370.'}, {'pmid': '9560538', 'type': 'RESULT', 'citation': 'Koyama S, Koh H, Noda K, Tagami N, Asada A. [A comparison of the incidence of postoperative nausea and vomiting after propofol-fentanyl anesthesia and that after nitrous oxide-isoflurane anesthesia]. Masui. 1998 Mar;47(3):286-9. Japanese.'}, {'pmid': '10735670', 'type': 'RESULT', 'citation': 'Hautmann H, Bauer M, Pfeifer KJ, Huber RM. Flexible bronchoscopy: a safe method for metal stent implantation in bronchial disease. Ann Thorac Surg. 2000 Feb;69(2):398-401. doi: 10.1016/s0003-4975(99)01398-3.'}, {'pmid': '9743396', 'type': 'RESULT', 'citation': 'Cartwright CR, Henson LC, Ward DS. Effects of alfentanil on the ventilatory response to sustained hypoxia. Anesthesiology. 1998 Sep;89(3):612-9. doi: 10.1097/00000542-199809000-00009.'}, {'pmid': '657853', 'type': 'RESULT', 'citation': 'Pereira W Jr, Kovnat DM, Snider GL. A prospective cooperative study of complications following flexible fiberoptic bronchoscopy. Chest. 1978 Jun;73(6):813-6. doi: 10.1378/chest.73.6.813.'}, {'pmid': '8404160', 'type': 'RESULT', 'citation': "Clarkson K, Power CK, O'Connell F, Pathmakanthan S, Burke CM. A comparative evaluation of propofol and midazolam as sedative agents in fiberoptic bronchoscopy. Chest. 1993 Oct;104(4):1029-31. doi: 10.1378/chest.104.4.1029."}]}, 'descriptionModule': {'briefSummary': 'The objective of the study was to establish which anesthetic procedure used during flexible bronchoscopy has the lowest index of complications.', 'detailedDescription': 'This prospective randomized study analyzed 80 patients that underwent flexible bronchoscopy. Patients were randomly assigned to four groups of 20 patients each according to the anesthetic combination used: 200 mg topical lidocaine (LID group); 200 mg topical lidocaine and 2 mg/kg propofol (PPF group); 200 mg topical lidocaine and 20 mcg/kg alfentanil (ALF group); or 200 mg topical lidocaine and 0.05 mg/kg midazolam (MID group). Scores were assigned to patients according to the different variables observed during the endoscopic procedure; the lower the score, the lower the complication index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients included in this study were referred to FBC for the investigation of bronchial carcinoma (diagnostic procedure).\n* Patients included in the study were classified as ASA I, II and II according to the anesthetic risk classification of the American Society of Anesthesiologists (ASA).\n\nExclusion Criteria:\n\n* ASA IV classification of anesthesiology risk\n* procedure that lasted longer than 15 minutes\n* indication of therapeutic bronchoscopy\n* cardiac arrhythmia and / or hypoxemia detected at admission.'}, 'identificationModule': {'nctId': 'NCT00440960', 'briefTitle': 'Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Pompeia'}, 'orgStudyIdInfo': {'id': '0002.0.297.000-06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'propofol', 'type': 'DRUG'}, {'name': 'midazolam', 'type': 'DRUG'}, {'name': 'alfentanil', 'type': 'DRUG'}, {'name': 'lidocaine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95010-005', 'city': 'Caxias do Sul', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Pompeia', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}, {'zip': '95040-000', 'city': 'Caxias do Sul', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Medianeira', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}, {'zip': '95070-560', 'city': 'Caxias do Sul', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'General Hospital of Universidade de Caxias do Sul', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}], 'overallOfficials': [{'name': 'Andre GS Leite, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brazilian Society of Thoracic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Pompeia', 'class': 'OTHER'}}}}