Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT02330120
Status:
COMPLETED
Last Update Posted:
2015-12-10
First Post:
2014-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], '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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-09', 'studyFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2014-12-31', 'lastUpdatePostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'airway resistance', 'timeFrame': '60 minutes', 'description': 'airway resistans measured by Evita 4 ventilator flow sensor'}, {'measure': 'peak airway pressure values', 'timeFrame': '60 minutes', 'description': 'peak airway pressure values provide the methods used to Evita 4 ventilator flow sensor'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peak airway pressure', 'airway resistance', 'sedation', 'intensive care'], 'conditions': ['Abnormal Respiratory Airway Resistance']}, 'referencesModule': {'references': [{'pmid': '16527548', 'type': 'BACKGROUND', 'citation': 'Fernandes FC, Ferreira HC, Cagido VR, Carvalho GM, Pereira LS, Faffe DS, Zin WA, Rocco PR. Effects of dexmedetomidine on respiratory mechanics and control of breathing in normal rats. Respir Physiol Neurobiol. 2006 Dec;154(3):342-50. doi: 10.1016/j.resp.2006.02.002. Epub 2006 Mar 9.'}, {'pmid': '24624271', 'type': 'BACKGROUND', 'citation': 'Bang SR, Lee SE, Ahn HJ, Kim JA, Shin BS, Roe HJ, Sim WS. Comparison of respiratory mechanics between sevoflurane and propofol-remifentanil anesthesia for laparoscopic colectomy. Korean J Anesthesiol. 2014 Feb;66(2):131-5. doi: 10.4097/kjae.2014.66.2.131. Epub 2014 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary mechanics in intensive care patients.', 'detailedDescription': 'The aim of this study is to compare the effects propofol and dexmedetomidine on pulmonary mechanics. Sixty patients mechanically ventilated in intensive care unit are included in this study. Patients are divided into two random groups, Group P (propofol) and Group D (dexmedetomidine). Propofol infusion 0.5-2 mg/kg/h is given to Group P patients and dexmedetomidine infusion 0.2-0.7 mcg/kg/h is given to Group D patients for sedation. Initial blood gas analysis, airway resistance (cmH2O/L/sec), positive end-expiratory pressure (PEEP, cmH20), frequency (breath/min), tidal volume (mL/min), minute volume (mL), peak airway pressure (cmH20), compliance (mL/cmH20), endtidal CO2 (mmHg), SvO2 (%) values are recorded. This parameters are evaluated with Drager Evita 4 ventilator and recorded on 5th,15th,30th,45th ve 60th minutes . Sedation is observed using Riker and Ramsey Sedation-Agitation Scale. Compliance of patients to mechanical ventilation is observed and recorded.\n\nThe primary outcome measures are airway resistance and peak airway pressure. Secondary outcome measure is sedation score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients mechanically ventilated in intensive care unit\n\nExclusion Criteria:\n\n* Patients with contraindications for using propofol and dexmedetomidine'}, 'identificationModule': {'nctId': 'NCT02330120', 'briefTitle': 'Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'orgStudyIdInfo': {'id': 'intensive care'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'propofol', 'description': 'Propofol infusion 0.5-2 mg/kg/h for sedation in mechanically ventilated patients', 'interventionNames': ['Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'description': 'dexmedetomidine infusion 0.2-0.7 mcg/kg/h for sedation in mechanically ventilated patients', 'interventionNames': ['Drug: dexmedetomidine']}], 'interventions': [{'name': 'propofol', 'type': 'DRUG', 'armGroupLabels': ['propofol']}, {'name': 'dexmedetomidine', 'type': 'DRUG', 'armGroupLabels': ['dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01130', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cukurova University', 'investigatorFullName': 'mediha turktan', 'investigatorAffiliation': 'Cukurova University'}}}}