Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-25 @ 4:16 AM
Study NCT ID:
NCT02743104
Status:
SUSPENDED
Last Update Posted:
2017-04-28
First Post:
2016-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D001285', 'term': 'Atropine'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'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': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'whyStopped': 'Protocol being reconsidered', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-27', 'studyFirstSubmitDate': '2016-04-10', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Overall Pulmonologist's satisfaction level (VAS)", 'timeFrame': '2 years', 'description': 'Assessed via visual analog scale'}], 'secondaryOutcomes': [{'measure': 'Amount of airway secretions', 'timeFrame': '2 years', 'description': 'Assessed via visual analog scale'}, {'measure': 'Cough score', 'timeFrame': '2 years', 'description': 'Assessed via visual analog scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Paediatric Flexible Bronchoscopy']}, 'referencesModule': {'references': [{'pmid': '16146472', 'type': 'BACKGROUND', 'citation': 'Hwang J, Jeon Y, Park HP, Lim YJ, Oh YS. Comparison of alfetanil and ketamine in combination with propofol for patient-controlled sedation during fiberoptic bronchoscopy. Acta Anaesthesiol Scand. 2005 Oct;49(9):1334-8. doi: 10.1111/j.1399-6576.2005.00842.x.'}, {'pmid': '24976998', 'type': 'BACKGROUND', 'citation': 'Dal T, Sazak H, Tunc M, Sahin S, Yilmaz A. A comparison of ketamine-midazolam and ketamine-propofol combinations used for sedation in the endobronchial ultrasound-guided transbronchial needle aspiration: a prospective, single-blind, randomized study. J Thorac Dis. 2014 Jun;6(6):742-51. doi: 10.3978/j.issn.2072-1439.2014.04.10.'}, {'pmid': '22045879', 'type': 'BACKGROUND', 'citation': 'Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.'}, {'pmid': '16162784', 'type': 'BACKGROUND', 'citation': 'Stolz D, Chhajed PN, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: a randomized, double-blind, placebo-controlled trial. Chest. 2005 Sep;128(3):1756-60. doi: 10.1378/chest.128.3.1756.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ketamine or propofol, drugs used for procedural sedation during paediatric bronchoscopy, results in higher operator satisfaction and better side effect profile.', 'detailedDescription': "Pediatric bronchoscopy requires moderate to deep sedation in order to maintain patient comfort and safety, while optimizing the working environment for the physician performing the procedure. There is a paucity of pediatric research in the field of pediatric flexible bronchoscopy and data are often extrapolated from adult studies.\n\nPropofol is often used as the sedation drug for this procedure due to its rapid sedative effect and favorable emergence profile. Propofol's major limitation is its tendency to cause apneas, which can occur in a relatively narrow therapeutic window. Apnea risk decreases with the patient's age and administering physician's familiarity and experience with the drug.\n\nKetamine is a drug often used for pediatric procedural sedation. Its pharmacologic safety profile is very wide, allowing a wide spectrum of dosing with a significantly reduced risk of apnea when compared to propofol. Known adverse effects of the drug include its emergence profile which may be accompanied by hallucinations, bronchorrhea and laryngospasm. Hallucinations may be prevented by using benzodiazepines concurrently and are possibly more pronounced in teenaged children compared to infants, although post-sedation irritability in the latter group might be an expression of this. Bronchorrhea, while usually not of significant concern during procedural sedation, has the potential to play a more noteworthy role during bronchoscopy. Significant airway secretions can create a difficult working environment for the pulmonologist performing the procedure. Patient safety may also be affected, as increased airway secretions reduce visibility in pediatric airways that are narrow to begin with and further compromised by placement of the bronchoscope. Potentially, this might also impact on the child's air flow and gas exchange. Laryngospasm during the procedure potentially hinders passage of the scope beyond the vocal cords and might extend the duration of the procedure.\n\nIn the investigators' center, propofol has most often been the sedative drug of choice for bronchoscopy. Yet, ketamine has been used at times due to its safety profile and the administering physicians level of comfort with each drug.\n\nAim:\n\nTo compare operator satisfaction and adverse effects in children presenting for flexible bronchoscopy using ketamine versus propofol as the primary sedative agent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children undergoing flexible bronchoscopy\n\nExclusion Criteria:\n\n* Failure to acquire parental consent\n* Bronchoscopies performed outside of the bronchoscopy suite\n* Bronchoscopies performed under general anesthesia with a protected airway\n* Bronchoscopies performed by personnel outside of the study group\n* Known allergies to either of the sedation drugs used'}, 'identificationModule': {'nctId': 'NCT02743104', 'briefTitle': 'Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy', 'orgStudyIdInfo': {'id': 'KP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine for procedural sedation', 'description': 'All patients will be sedated according to a written protocol which includes intravenous administration of midazolam and atropine. In addition, local anesthesia will be performed using lidocaine 1% sprayed once just above the vocal cords, and again at the level of the carina. Lidocaine doses are limited to a maximum total dose of 5mg/kg.\n\nThis study group will be exposed to ketamine as the main drug for sedation, as an initial bolus of 1-2 mg/kg initially and then titrated by additional doses of 1mg/kg per dose.', 'interventionNames': ['Drug: Ketamine', 'Drug: midazolam and atropine', 'Drug: Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol for procedural sedation', 'description': 'All patients will be sedated according to a written protocol which includes intravenous administration of midazolam and atropine. In addition, local anesthesia will be performed using lidocaine 1% sprayed once just above the vocal cords, and again at the level of the carina. Lidocaine doses are limited to a maximum total dose of 5mg/kg.\n\nThis study group will be exposed to propofol as the main drug for sedation, as an initial bolus of 1-2 mg/kg initially and then titrated by additional doses of 1mg/kg per dose.', 'interventionNames': ['Drug: Propofol', 'Drug: midazolam and atropine', 'Drug: Lidocaine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar'], 'armGroupLabels': ['Ketamine for procedural sedation']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'armGroupLabels': ['Propofol for procedural sedation']}, {'name': 'midazolam and atropine', 'type': 'DRUG', 'armGroupLabels': ['Ketamine for procedural sedation', 'Propofol for procedural sedation']}, {'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Ketamine for procedural sedation', 'Propofol for procedural sedation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Group data will be published. No individual data will be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}