Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT01752959
Status:
UNKNOWN
Last Update Posted:
2012-12-19
First Post:
2012-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Esmolol and Remifentanil to Reduce Blood Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'C036604', 'term': 'esmolol'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-17', 'studyFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2012-12-17', 'lastUpdatePostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the difference between group regarding blood loss', 'timeFrame': 'intraoperative', 'description': 'controlled hypotension in nasal surgery'}], 'secondaryOutcomes': [{'measure': 'the difference between groups regarding side effects and treatments', 'timeFrame': 'intraoperative', 'description': 'side effects: more than 20% change in blood pressure and heart rate, treatment includes atropin, ephedrin, nitroglyserine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Deviation Septum Nasal']}, 'referencesModule': {'references': [{'pmid': '11212044', 'type': 'BACKGROUND', 'citation': 'Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.'}, {'pmid': '22185726', 'type': 'BACKGROUND', 'citation': 'Shen PH, Weitzel EK, Lai JT, Wormald PJ, Ho CS. Intravenous esmolol infusion improves surgical fields during sevoflurane-anesthetized endoscopic sinus surgery: a double-blind, randomized, placebo-controlled trial. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e208-11. doi: 10.2500/ajra.2011.25.3701.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective randomized study we aimed to compare the effects of esmolol and remifentanil on intraoperative bleeding surgical field conditions in nasal surgery', 'detailedDescription': '60 patients with ASA I-IIphysical status assigned for septoplasty will be enrolled in this prospective randomized trial. A standardized anesthesia induction and intubation with propofol and rocuronium will be used. Patients will be randomized in two groups. Group Esmolol (Group E n=30) will receive esmolol 500 mic kg-1 loading dose and a 50-500 mic kg-1 min-1 infusion and Group Remifentanil (Group R n=30) will receive remifentanil 0.1-0.3 mic kg-1 min-1 infusion to induce controlled hypotension. A 50-60 mmHg mean arterial pressure and a minimum 50 beat min-1 heart rate is targeted. Heart rate, blood pressures, peripheral oxygen saturation and bispectral index spectrum (BIS) will be recorded. Anesthesia maintenance will be provided with O2/N2O and desflurane-propofol balanced anesthesia and a BIS value 40-60 is targeted. The quality of the surgical field will be assessed by the surgeon by using a 10 point visual analog scale (B1) and a 6 point scale (B2) during surgery with 5 minute intervals. The amount of bleeding will be calculated at the end of surgery from the amount of blood and irrigation fluid collected in the suction tube. All complications and side effects will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II,\n* between age 20-60\n\nExclusion Criteria:\n\n* patients having bleeding disorders,\n* arrhythmia,\n* hypertension,\n* endocrine, liver or kidney disease and\n* those who are on antihypertensive,\n* anticoagulant drugs'}, 'identificationModule': {'nctId': 'NCT01752959', 'briefTitle': 'A Comparison of Esmolol and Remifentanil to Reduce Blood Loss', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery', 'orgStudyIdInfo': {'id': 'RAcikgozEsmolol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanyl', 'description': 'Group R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'esmolol', 'description': 'Grup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion', 'interventionNames': ['Drug: Esmolol']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': '0.1-0.3 micg/kg/min Remifentanil iv infusion', 'armGroupLabels': ['Remifentanyl']}, {'name': 'Esmolol', 'type': 'DRUG', 'otherNames': ['Brevibloc'], 'description': '500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion', 'armGroupLabels': ['esmolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'status': 'COMPLETED', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Yildirim Beyazit Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06610', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Murat Alper, Proffesor', 'role': 'CONTACT', 'email': 'muratalper@hotmail.com', 'phone': '03125962242'}], 'facility': 'Diskapi Yildirim Beyazit Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ruveyda D Acikgoz, Trainee', 'role': 'CONTACT', 'phone': '0903125962554'}, {'name': 'Dilek Yazicioglu, Specialist', 'role': 'CONTACT', 'email': 'dilek.yazicioglu@hotmail.com', 'phone': '0903125962553'}], 'overallOfficials': [{'name': 'Ruveyda D Acıkgoz, Trainee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor Trainee in Anesthesiology and Reanimation', 'investigatorFullName': 'Dondu Ruveyda Acikgoz', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}