Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT03077503
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2017-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'After written informed consents were obtained, all participant was blinded from the study drug. The study drugs (dexmedetomidine and fentanyl) were prepared by anesthetist nurse who not involved in the study. Dexmedetomidine was labeled with group A whereas fentanyl was labeled with group B. The study drug was administrated by the blinded anesthiologist. Blood pressure, mean arterial pressure, and heart rate were recorded by same blinded anesthesiologist'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, double-blinded controlled trial was conducted from September 2015 to September 2016 in Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand. Sixty patients who underwent craniotomy with insertion of skull pin were randomly allocated into group A and B. After patients entered the operative room, blood pressure and heart rate were measured (T1) then repeated measurement again (T2) when started induction, intubation and infusion dexmedetomidine 1 µg/kg over 10 min infusion in group A whereas group B received normal saline. At 3 minutes before skull pin insertion (T3), patient in group B received a single bolus of fentanyl 1 µg/kg whereas group A received normal saline. Then hemodynamic responses were recorded and repeated again at one minute before skull pin insertion (T4). Blood pressure and heart rate were observed at the time of skull pin insertion (T5) then repeated every 1 minutes after skull pin application until 5 minutes (T6 - T10).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2017-03-04', 'studyFirstSubmitQcDate': '2017-03-07', 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': 'Baseline in time frame before pin insertion (T1-T4) , time during pin insertion (T5), repeated measurement time every 1 minute until 5 minutes after pin applications (T6-T10).', 'description': 'Blood pressure was recorded by the blinded anesthesiologist'}], 'secondaryOutcomes': [{'measure': 'Change in mean arterial pressure', 'timeFrame': 'Baseline in time frame before pin insertion (T1-T4), time during pin insertion (T5), repeated measurement time every 1 minute until 5 minutes after pin applications (T6-T10).', 'description': 'Mean arterial pressure was recorded by the blinded anesthesiologist'}, {'measure': 'Change in heart rate', 'timeFrame': 'Baseline in time frame before pin insertion (T1-T4), time during pin insertion (T5), repeated measurement time every 1 minute until 5 minutes after pin applications (T6-T10).', 'description': 'Heart rate was recorded by the blinded anesthesiologist'}, {'measure': 'adverse events', 'timeFrame': 'Baseline in time frame before pin insertion (T1-T4), time during pin insertion (T5), repeated measurement time every 1 minute until 5 minutes after pin applications (T6-T10).', 'description': 'Adverse events were recorded by the blinded anesthesiologist. Rescue drugs were give when adverse events were occurred. Rescue drug include propofol (for hypertension), ephedrine(for hypotension), esmolol (for tachycardia), atropine (for bradycardia)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodynamic response', 'Skull pins application', 'Dexmedetomidine', 'Fentanyl'], 'conditions': ['Hemodynamic Response', 'Skull Pins Application']}, 'referencesModule': {'references': [{'pmid': '26903671', 'type': 'RESULT', 'citation': 'Paul A, Krishna HM. Comparison between intravenous dexmedetomidine and local lignocaine infiltration to attenuate the haemodynamic response to skull pin head holder application during craniotomy. Indian J Anaesth. 2015 Dec;59(12):785-8. doi: 10.4103/0019-5049.171558.'}]}, 'descriptionModule': {'briefSummary': 'To compare the effect between dexmedetomidine and fentanyl for controlling the hemodynamic response to skull pins application', 'detailedDescription': 'A randomized, double-blinded controlled trial was conducted from September 2015 to September 2016 in Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand. Sixty patients who underwent craniotomy with insertion of skull pin were randomly allocated into group A and B. After patients entered the operative room, blood pressure and heart rate were measured (T1) then repeated measurement again (T2) when started induction, intubation and infusion dexmedetomidine 1 µg/kg over 10 min infusion in group A whereas group B received normal saline. At 3 minutes before skull pin insertion (T3), patient in group B received a single bolus of fentanyl 1 µg/kg whereas group A received normal saline. Then hemodynamic responses were recorded and repeated again at one minute before skull pin insertion (T4). Blood pressure and heart rate were observed at the time of skull pin insertion (T5) then repeated every 1 minutes after skull pin application until 5 minutes (T6 - T10).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who scheduled for elective craniotomy under general anesthesia\n* patient with American Society of Anesthesiologists physical status classification of I and II\n\nExclusion Criteria:\n\n* patients having body mass index more than 30 kg/m2, heart rate lower than 45 bpm, hypertension, ischemic heart disease, heart block, on beta adrenergic blockers, medication allergy including propofol, fentanyl, and dexmedetomidine.'}, 'identificationModule': {'nctId': 'NCT03077503', 'briefTitle': 'Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application in Neurosurgery:Double Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HE581303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine (Group A)', 'description': 'In induction period, group A received dexmedetomidine 1 µg/kg diluted to 20 ml with 0.9% normal saline 10 minute through a syringe pump. Three minutes before application of skull pins, group A received infusion of 2 ml of 0.9% normal saline.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: 0.9% normal saline', 'Device: Skull pins']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl (group B)', 'description': 'In induction period, group B received 20ml of 0.9% normal saline.Three minutes before application of skull pins, group B received infusion of fentanyl 1 µg/kg diluted to 2 ml with 0.9% normal saline', 'interventionNames': ['Drug: Fentanyl', 'Drug: 0.9% normal saline', 'Device: Skull pins']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'Dexmedetomidine 1 µg/kg diluted to 20 ml with 0.9% normal saline was administration. If adverse events were occurred, the patient will receive rescue drugs.', 'armGroupLabels': ['Dexmedetomidine (Group A)']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl 1 µg/kg diluted to 2 ml with 0.9% normal saline was administration. If adverse events were occurred, the patient will receive rescue drugs.', 'armGroupLabels': ['Fentanyl (group B)']}, {'name': '0.9% normal saline', 'type': 'DRUG', 'description': '0.9% normal saline was use to dilute the study drugs', 'armGroupLabels': ['Dexmedetomidine (Group A)', 'Fentanyl (group B)']}, {'name': 'Skull pins', 'type': 'DEVICE', 'otherNames': ['Mayfield'], 'description': "Skull pins were use to stabilized the patent' s head during surgery", 'armGroupLabels': ['Dexmedetomidine (Group A)', 'Fentanyl (group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Pornthep Kasemsiri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Khon Kaen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Pornthep Kasemsiri', 'investigatorAffiliation': 'Khon Kaen University'}}}}