Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 3:05 AM
Study NCT ID:
NCT06951256
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block vs Bupivacaine Alone for Hemodynamics Stability in Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-26', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-04-26', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative mean arterial pressure measured after Mayfeild insertion during craniotomies.', 'timeFrame': 'During the operation', 'description': 'Mean blood pressure (MAP) was monitored continuously and recorded at Base line, before Mayfield placement, after 5mins of Mayfield insertion and at the end of surgery. The hemodynamic parameters at each step of recording were compared between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Surgeon satisfaction as regard surgical field. Postoperative VAS score and time for 1st rescue analgesia. Total analgesic consumption in first 24 hours postoperative.', 'timeFrame': 'During 24 hours', 'description': '1. Heart rate was monitored continuously and recorded at Base line, before Mayfield placement, after 5mins of Mayfield insertion and at the end of surgery. The hemodynamic parameters at each step of recording were compared between the two groups.\n2. Intraoperative surgeon satisfaction:\n\n Surgeon satisfaction regard surgical field was assessed and recorded according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor).\n3. Assessment of post-operative pain:\n\nPost operatively, the patient was transferred to the PACU where pain intensity was evaluated on a (0-10) visual analog scale (VAS)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scalp block', 'Mean arterial pressure stability', 'Dexmedetomidine', 'Craniotomy'], 'conditions': ['Dexmedetomidine', 'Craniotomy', 'Regional Anesthesia', 'Mean Arterial Pressure Stability']}, 'descriptionModule': {'briefSummary': 'The investigator tested the effect of dexmedetomidine as an adjuvant to bupivacaine compared to bupivacaine alone in mean arterial pressure stability in adult patients undergoing craniotomy', 'detailedDescription': "A) Preoperative settings:\n\nComplete history taking and full physical examination. Routine preoperative investigations was done to all patients including laboratory investigations (complete blood picture, liver function tests, prothrombin time and partial thromboplastin time) and other as needed by the patient condition.\n\nWritten informed consent was obtained from all participants prior to the study. Patients was educated visual analogue score for pain (VAS), which consisted of 10c.m line, with two end points (where 0=no pain and 10=worst pain).\n\nB) Intraoperative settings:\n\nElectrocardiogram (ECG), non-invasive blood pressure (NIBP), pulse oximeter (SpO2) will be applied, and baseline readings were taken before induction, no sedation was given.\n\nAnesthesia was induced after a period of preoxygenation with 100% oxygen for 2-3 minutes with intravenous injection of fentanyl 2 µg/kg .propofol 2 mg/kg ) and a muscle relaxant (Atracurium) 0.5 mg/kg after loss of patient consciousness.\n\nAfter endotracheal intubation, intubation was confirmed by ETCO2 and bilateral auscultation of the chest.\n\nAnesthesia was maintained with 60% oxygen mixed with air and isoflurane 1-2%. Lungs were ventilated using volume-controlled ventilation with tidal volumes and respiratory rate adjusted to maintain end tidal CO2 at 35-40 mmHg.\n\nFollowing anesthesia induction, a continuous invasive blood pressure monitoring was initiated through radial 20-gauge arterial catheterization, as well as urine output through bladder catheterization.\n\nSampling method:\n\nThe patients were randomly divided into two equal groups using a computerized generated list (closed opaque sealed envelope).\n\nGroup SB (n =18 patient) received scalp block with Bupivacaine alone. Group SD (n =18 patient) received scalp block with Dexmedetomidine as an adjuvant to Bupivacaine.\n\nIn both group:\n\nScalp nerve block was done by anesthesiologist who is blind to the drug being injected and under complete septic condition where local infiltration of local anesthetic (LA) was done guided by bony superficial landmarks to block the supraorbital, supratrochlear, auriculotemporal, occipital, and post auricular branches of the greater auricular nerves as follow :\n\nThe patient lied supine on the table while the performing operator usually stands at the head end facing the feet.\n\nThe supraorbital and supratrochlear nerves were blocked with 2 mL of solution as they emerge from the orbit with needle introduced above the eyebrow perpendicular to the skin. The supraorbital notch was located by palpation, and the needle was introduced perpendicularly 1 cm medial to the notch.\n\nThe auriculotemporal nerves was performed with the patient's head turned to one side so that the side to be blocked faces upward with 3 mL of solution injected 1.5 cm anterior to the ear at the level of the tragus; the needle was introduced perpendicular to the skin and infiltration made deep to the fascia and superficially as the needle withdrawn. The superficial temporal artery should be palpated to avoid intra-arterial injection. Negative aspiration is a must for this block.\n\nThe post auricular branches of the greater auricular nerves were blocked with 2 mL of solution between skin and bone, 1.5 cm posterior to the ear at the level of the tragus The needle was inserted at 90 degrees till bony contact is made, upon which it is withdrawn, and subcutaneous injection was performed.\n\nThe greater, lesser, and third occipital nerves were blocked with 3 mL of solution with infiltration along the superior nuchal line, approximately halfway between the occipital protuberance and the mastoid process.\n\nIn Group SB: (LA) was done by 20ml of Bupivacaine 0.25%.\n\nWhile Group SD:\n\nlocal infiltration of total volume 20ml which include (Bupivacaine 0.25%. + Dexmedetomidine 1mcg/kg) was done.\n\nIn both group maximal dose of Bupivacaine didn't not exceed (2.5 mg/kg) . Dexmedetomidine preparation was done by 2ml (200 mcg) diluted by 18 ml normal saline in 20 ml syringe as 1ml was contain 10 mcg and used.\n\nMayfield placement in all patients was done 15 minutes after scalp block was given.\n\n\\*Both blocks was done \\& or supervised by an expert all through. At the end of the surgery, the residual neuromuscular block was be reversed with intravenous injection of neostigmine (0.05 mg/kg) with atropine (0.01 mg/kg), Endotracheal tube extubation was done and then the patient was transferred to Postoperative anesthesia care unit (PACU)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged from 18 to 65 years.\n* Patients ASA I or II undergoing supratentorial elective planned craniotomies.\n\nExclusion Criteria:\n\n* Patients refused to participate in the study.\n* Patients with cardiovascular diseases such as hypertension or low cardiac reserve.\n* History or known allergy to the used local anesthetic or opioids.\n* Patient could not understand a visual analog scale (VAS).\n* Bleeding disorders.\n* Evidence of local infection at site of injection. 7. Emergency craniotomy'}, 'identificationModule': {'nctId': 'NCT06951256', 'briefTitle': 'Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block vs Bupivacaine Alone for Hemodynamics Stability in Craniotomy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Intraoperative Mean Arterial Pressure Stability in Adult Patients Undergoing Craniotomy', 'orgStudyIdInfo': {'id': 'FMASU MS78/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group SB (n =18 patient) will receive scalp block with Bupivacaine alone.', 'description': 'In Group SB: 20 ml of Bupivacaine 0.25% was given Scalp nerve block was done under complete aseptic condition where local infiltration of local anesthetic (LA) was done guided by bony superficial landmarks to block the supraorbital, supratrochlear, auriculotemporal, occipital, and post auricular branches of the greater auricular nerves.\n\nIn both group maximal dose of Bupivacaine was not exceed (2.5 mg/kg).', 'interventionNames': ['Drug: Scalp block with bupivacaine alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group SD (n =18 patient) will receive scalp block with dexmedetomidine as an adjuvant to Bupivacaine', 'description': 'In group SD: local infiltration of total volume 20 ml which include (Bupivacaine 0.25%. + Dexmedetomidine 1 mcg/kg) was given.\n\nDexmedetomidine preparation was done by 2 ml (200 mcg) diluted by 18 ml normal saline in 20 ml syringe as 1 ml was contained 10 mcg and was used.\n\nScalp block was given by the same way as group SB. In both group maximal dose of Bupivacaine was not exceed (2.5 mg/kg).', 'interventionNames': ['Drug: Scalp block by adding dexmedetomidine as an adjuvant to bupivacaine']}], 'interventions': [{'name': 'Scalp block with bupivacaine alone', 'type': 'DRUG', 'otherNames': ['Traditional scalp block'], 'description': 'In Group SB: (LA) was done by 20ml of Bupivacaine 0.25%. maximal dose of Bupivacaine did not exceed (2.5 mg/kg) Scalp nerve block will be done by anesthesiologist who is blind to the drug being injected and under complete septic condition where local infiltration of local anesthetic (LA) will be done guided by bony superficial landmarks to block the supraorbital, supratrochlear, auriculotemporal, occipital, and post auricular branches of the greater auricular nerves', 'armGroupLabels': ['Group SB (n =18 patient) will receive scalp block with Bupivacaine alone.']}, {'name': 'Scalp block by adding dexmedetomidine as an adjuvant to bupivacaine', 'type': 'DRUG', 'otherNames': ['Scalp block by dexmedetomidine', 'Dexmedetomidine', 'Dexmedetomidine as an adjuvant to bupivacaine'], 'description': 'local infiltration of total volume 20ml which include (Bupivacaine 0.25%. + Dexmedetomidine 1mcg/kg) was done Dexmedetomidine preparation was done by 2ml (200 mcg) diluted by 18 ml normal saline in 20 ml syringe as 1ml was contain 10 mcg and injected at same points as above', 'armGroupLabels': ['Group SD (n =18 patient) will receive scalp block with dexmedetomidine as an adjuvant to Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Cairo', 'state': 'Egypt', 'country': 'Egypt', 'facility': 'Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Yara Sa Ghareb, MBBCH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'After paper publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}