Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 6:52 PM
Study NCT ID:
NCT03738059
Status:
UNKNOWN
Last Update Posted:
2018-12-19
First Post:
2018-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Lowest Effective Dose of Dexmedetomidine in Attenuating the Hemodynamic Responses During Skull Pin Insertion in Patients Undergoing Elective Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-16', 'studyFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arterial blood pressure change', 'timeFrame': 'before Skull Pin Insertion till 20 minutes', 'description': 'systolic and diastolic blood pressure mmhg'}, {'measure': 'heart rate change', 'timeFrame': 'before Skull Pin Insertion till 20 minutes', 'description': 'heart rate beat/minute'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skull Pin Insertion', 'Dexmedetomidine', 'Hemodynamic Responses'], 'conditions': ['Skull Pin Insertion']}, 'referencesModule': {'references': [{'pmid': '9174309', 'type': 'BACKGROUND', 'citation': 'Jamali S, Archer D, Ravussin P, Bonnafous M, David P, Ecoffey C. The effect of skull-pin insertion on cerebrospinal fluid pressure and cerebral perfusion pressure: influence of sufentanil and fentanyl. Anesth Analg. 1997 Jun;84(6):1292-6. doi: 10.1097/00000539-199706000-00022.'}, {'pmid': '2655365', 'type': 'BACKGROUND', 'citation': 'Levin R, Hesselvik JF, Kourtopoulos H, Vavruch L. Local anesthesia prevents hypertension following application of the Mayfield skull-pin head holder. Acta Anaesthesiol Scand. 1989 May;33(4):277-9. doi: 10.1111/j.1399-6576.1989.tb02907.x.'}, {'pmid': '19262392', 'type': 'BACKGROUND', 'citation': 'Geze S, Yilmaz AA, Tuzuner F. The effect of scalp block and local infiltration on the haemodynamic and stress response to skull-pin placement for craniotomy. Eur J Anaesthesiol. 2009 Apr;26(4):298-303. doi: 10.1097/EJA.0b013e32831aedb2.'}, {'pmid': '29628584', 'type': 'BACKGROUND', 'citation': 'Nagappa S, Kalappa S, Sridhara RB. Evaluation of the Hemodynamic Response of Intravenous Clonidine versus Ropivacaine Scalp Block to Insertion of Scalp Pins in Neurosurgical Patients. Anesth Essays Res. 2018 Jan-Mar;12(1):213-217. doi: 10.4103/0259-1162.194572.'}, {'pmid': '26889282', 'type': 'BACKGROUND', 'citation': 'Bharne S, Bidkar PU, Badhe AS, Parida S, Ramesh AS. Comparison of intravenous labetalol and bupivacaine scalp block on the hemodynamic and entropy changes following skull pin application: A randomized, open label clinical trial. Asian J Neurosurg. 2016 Jan-Mar;11(1):60-5. doi: 10.4103/1793-5482.165801.'}]}, 'descriptionModule': {'briefSummary': 'Skull pins are used to immobilize the head during craniotomy. Fixation of skull pins causes acute hemodynamic changes which may affect cerebral autoregulation and hence cerebral blood flow. Therefore, maintenance of stable hemodynamic parameters during skull pin placement under general anesthesia is crucial to ensure adequate cerebral perfusion and prevention of acute rise of intracranial pressure', 'detailedDescription': 'Many different strategies have been used to minimize the hemodynamic responses to skull pin placement with varying results. Local anesthetic infiltration at pin application sites has been used but was always unsuccessful in obtunding the hemodynamic responses to skull pin placement. Dexmedetomidine, an alpha-2 adrenoceptor agonist, has been recently introduced as a sedative for patients on mechanical ventilation. In addition to its sedative effect; Dexmedetomidine has significant analgesic qualities and has been labeled as "analgesia-sparing". To the best of the investigator\'s knowledge, few studies investigated Dex use to suppress hemodynamic responses to skull pinning. The aim of the current study was to evaluate the lowest effective dose of Dexmedetomidine in attenuating the hemodynamic responses to skull pin placement for craniotomies. Lidocaine, administered subcutaneously at the head-holder pin sites, was more effective in preventing the blood pressure response to skull-pin than was deepening the level of anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 120 Adult patients,\n* undergoing elective craniotomy\n* ASA I and II patients\n\nExclusion Criteria:\n\n* patients undergoing craniotomy for emergency surgery,\n* raised ICP,\n* obese patients (body mass index \\>30 kg/m2 for males and 28 kg/m2 for females),\n* patients having systemic comorbidities (cardiac, renal, hepatic, and endocrinal),\n* hypertensive patients (including those detected after admission),\n* patients undergoing intracranial aneurysm clipping'}, 'identificationModule': {'nctId': 'NCT03738059', 'briefTitle': 'The Lowest Effective Dose of Dexmedetomidine in Attenuating the Hemodynamic Responses During Skull Pin Insertion in Patients Undergoing Elective Craniotomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of the Lowest Effective Dose of Dexmedetomidine in Attenuating the Hemodynamic Responses During Skull Pin Insertion in Patients Undergoing Elective Craniotomy: Randomized Control Study', 'orgStudyIdInfo': {'id': '17300238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'group I (placebo)', 'description': 'will receive intravenous normal saline (NS)', 'interventionNames': ['Other: normal saline 0.9%']}, {'type': 'EXPERIMENTAL', 'label': 'group II (Dex 0.5)', 'description': 'will receive intravenous Dex 0.5 mcg/kg', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]']}, {'type': 'EXPERIMENTAL', 'label': 'group III (Dex 0.25)', 'description': 'will receive intravenous Dex 0.25 mcg/kg', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]']}, {'type': 'EXPERIMENTAL', 'label': 'group IV (Dex 0.2)', 'description': 'will receive intravenous Dex 0.2 mcg/kg.', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]']}], 'interventions': [{'name': 'Dexmedetomidine Injection [Precedex]', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine'], 'description': 'will receive intravenous Dexmedetomidine', 'armGroupLabels': ['group II (Dex 0.5)', 'group III (Dex 0.25)', 'group IV (Dex 0.2)']}, {'name': 'normal saline 0.9%', 'type': 'OTHER', 'description': 'will receive intravenous normal saline 0.9%', 'armGroupLabels': ['group I (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ghada M Aboelfadl, MD', 'role': 'CONTACT', 'email': 'ghadafadl77@gmail.com', 'phone': '01005802086'}], 'facility': 'Assiut governorate', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ghada Mohammed Abo Elfadl, M.D', 'role': 'CONTACT', 'email': 'ghadafadl77@gmail.com', 'phone': '01005802086'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ghada Mohammed AboelFadl', 'investigatorAffiliation': 'Assiut University'}}}}