Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT01289769
Status:
COMPLETED
Last Update Posted:
2011-12-15
First Post:
2011-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-04-02', 'releaseDate': '2012-03-06'}, {'resetDate': '2012-05-10', 'releaseDate': '2012-04-13'}, {'resetDate': '2012-07-06', 'releaseDate': '2012-06-03'}, {'resetDate': '2012-08-15', 'releaseDate': '2012-07-08'}, {'resetDate': '2012-09-12', 'releaseDate': '2012-08-16'}, {'resetDate': '2013-03-13', 'releaseDate': '2013-02-11'}, {'resetDate': '2013-10-22', 'releaseDate': '2013-08-18'}], 'estimatedResultsFirstSubmitDate': '2012-03-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D013610', 'term': 'Tachycardia'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-14', 'studyFirstSubmitDate': '2011-02-01', 'studyFirstSubmitQcDate': '2011-02-03', 'lastUpdatePostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in systolic blood pressure', 'timeFrame': '(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation', 'description': 'direct arterial pressure monitoring'}, {'measure': 'change in diastolic blood pressure', 'timeFrame': '(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation', 'description': 'direct arterial pressure monitoring'}, {'measure': 'change in mean arterial pressure', 'timeFrame': '(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation', 'description': 'direct arterial pressure monitoring'}, {'measure': 'change in heart rate', 'timeFrame': '(day 1) before induction, before intubation and every minute for the first 10 minutes after endotracheal intubation'}], 'secondaryOutcomes': [{'measure': 'adverse events related to dexmedetomidine', 'timeFrame': '(day 1) during dexmedetomidine administration until 10 minutes after endotracheal intubation', 'description': 'bradycardia, hypotension, arrhythmia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intubation Complication', 'Tracheal Intubation Morbidity', 'Anesthesia Intubation Complication', 'Hypertension', 'High Blood Pressure', 'Tachycardia']}, 'referencesModule': {'references': [{'pmid': '18929283', 'type': 'BACKGROUND', 'citation': 'Basar H, Akpinar S, Doganci N, Buyukkocak U, Kaymak C, Sert O, Apan A. The effects of preanesthetic, single-dose dexmedetomidine on induction, hemodynamic, and cardiovascular parameters. J Clin Anesth. 2008 Sep;20(6):431-6. doi: 10.1016/j.jclinane.2008.04.007.'}, {'pmid': '11284817', 'type': 'BACKGROUND', 'citation': 'Maguire A, Thompson JP, Guest C, Sadler PJ, Strupish JW, West KJ. Comparison of the effects of intravenous alfentanil and esmolol on the cardiovascular response to double-lumen endobronchial intubation. Anaesthesia. 2001 Apr;56(4):319-25. doi: 10.1046/j.1365-2044.2001.01917.x.'}, {'pmid': '23983684', 'type': 'DERIVED', 'citation': 'Pipanmekaporn T, Punjasawadwong Y, Charuluxananan S, Lapisatepun W, Bunburaphong P. The effect of prophylactic dexmedetomidine on hemodynamic disturbances to double-lumen endotracheal intubation: a prospective, randomized, double-blind, and placebo-controlled trial. Anesthesiol Res Pract. 2013;2013:236089. doi: 10.1155/2013/236089. Epub 2013 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic responses during laryngoscopy and double lumen endotracheal intubation and assess the adverse effect related to complications of dexmedetomidine.', 'detailedDescription': 'The cardiovascular responses to laryngoscopy and tracheal intubation are mediated by both sympathetic and parasympathetic nervous system. The hemodynamic responses resulting from sympathetic nervous system stimulation are tachycardia, cardiac arrhythmias, hypertension, increased intraocular pressure, increased intracranial pressure, bronchospasm and myocardial ischemia. Tachycardia is one of the major predictor of intraoperative myocardial ischemia and causes an imbalance of myocardial oxygen supply and demand. Although hemodynamic responses to laryngoscopy and intubation is transient, these effect may be harmful to patients suffering from myocardial and cerebrovascular diseases. The placement of double lumen endotracheal tube may produce similar or greater pressor response than endotracheal tube because of larger sizes and greater carinal stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA Physical Status I-III\n* Undergoing Elective Thoracotomy or Thoracoscopy\n* Required Left Sided-double Lumen Endotracheal Intubation\n\nExclusion Criteria:\n\n* Patients with bradycardia (heart rate \\< 50 beat per minute) or heart block\n* Suspected of Difficult Intubation\n* Patients Who Are at Risk for Rapid Change of Hemodynamics\n* Allergic to Dexmedetomidine\n* Hepatic or Renal Impairment (Preoperative Serum Creatinine \\> 1.5 mg/dl)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01289769', 'briefTitle': 'The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'The Effect of Prophylactic Dexmedetomidine on Hemodynamic Disturbances During Double Lumen Endotracheal Intubation. A Double-blinded, Randomized, Placebo-Controlled Trial.', 'orgStudyIdInfo': {'id': 'COM-10-11-19B-11'}, 'secondaryIdInfos': [{'id': 'research ID 77', 'type': 'OTHER', 'domain': 'Research ID 77'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Maung', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University Hospital'}], 'overallOfficials': [{'name': 'Tanyong Pipanmekaporn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology, Faculty of Medicine', 'investigatorFullName': 'Tanyong Pipanmekaporn', 'investigatorAffiliation': 'Chiang Mai University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-03-06', 'type': 'RELEASE'}, {'date': '2012-04-02', 'type': 'RESET'}, {'date': '2012-04-13', 'type': 'RELEASE'}, {'date': '2012-05-10', 'type': 'RESET'}, {'date': '2012-06-03', 'type': 'RELEASE'}, {'date': '2012-07-06', 'type': 'RESET'}, {'date': '2012-07-08', 'type': 'RELEASE'}, {'date': '2012-08-15', 'type': 'RESET'}, {'date': '2012-08-16', 'type': 'RELEASE'}, {'date': '2012-09-12', 'type': 'RESET'}, {'date': '2013-02-11', 'type': 'RELEASE'}, {'date': '2013-03-13', 'type': 'RESET'}, {'date': '2013-08-18', 'type': 'RELEASE'}, {'date': '2013-10-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tanyong Pipanmekaporn, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University'}}}}