Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-04-18 @ 1:49 AM
Study NCT ID:
NCT02844894
Status:
UNKNOWN
Last Update Posted:
2016-07-26
First Post:
2016-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Response to Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'C036604', 'term': 'esmolol'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2016-07-22', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ischemia modified albumine', 'timeFrame': '10 minutes after endotracheal intubation', 'description': 'ischemia modified albumine levels will be measured as a response to intubation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intubation, ischemia modified albumine, dexmedetomidine, esmolol'], 'conditions': ['Intubation']}, 'referencesModule': {'references': [{'pmid': '25886340', 'type': 'RESULT', 'citation': 'Yallapragada SV, Vidadala KS, Vemuri NN, Shaik MS. Comparison of the efficacy of dexmedetomidine with that of esmolol in attenuating laryngoscopic and intubation response after rapid sequence induction. Anesth Essays Res. 2014 Sep-Dec;8(3):383-7. doi: 10.4103/0259-1162.143154.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of dexmedetomidine and esmolol given intravenously before intubation on sympathetic response caused by intubation itself. Half the patients will recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia modified albumine levels will be measured'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective surgery under general anesthesia\n\nExclusion Criteria:\n\n* Patient refusal\n* Morbid obesity (BMI\\>30)\n* Advanced systemic disease\n* Hypoalbumiemia\n* beta-blocker usage\n* Anticipated difficult ventilation and/or intubation'}, 'identificationModule': {'nctId': 'NCT02844894', 'briefTitle': 'Hemodynamic Response to Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Ufuk University'}, 'officialTitle': 'The Effects of Preintubation Esmolol and and Dexmedotimidine on Ischmeia Modified Albumin Levels', 'orgStudyIdInfo': {'id': 'RespToIntubation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine', 'description': '0.5 mcg/kg dexmedetomidine in 20 ml normal saline will be infused in 5 minutes before intubation', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Esmolol', 'description': '0.5 mg/kg esmolol in 20 ml normal saline will be infused in 5 minutes before intubation', 'interventionNames': ['Drug: Esmolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '20 ml normal saline infused in 5 minutes before intubation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'Esmolol', 'type': 'DRUG', 'armGroupLabels': ['Esmolol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'normal saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ulku C Koksoy, Fellow', 'role': 'CONTACT', 'email': 'cerenkoksoy@gmail.com', 'phone': '+903122044000', 'phoneExt': '4099'}], 'facility': 'Ufuk University Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Perihan Ekmekçi, Ass Prof', 'role': 'CONTACT', 'email': 'erdogduperi@gmail.com', 'phone': '+903122044000', 'phoneExt': '4099'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ufuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Perihan Ekmekçi', 'investigatorAffiliation': 'Ufuk University'}}}}