Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-04-14 @ 10:50 PM
Study NCT ID:
NCT05793060
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2023-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]', 'timeFrame': '24 hours after the end of the operation', 'description': 'NPRS measures the severity of pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain ( At post anesthesia care unit (PACU), then every 2 hours till 24 hours)'}, {'measure': 'Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)', 'timeFrame': '24 hours after the end of the operation', 'description': 'NPRS measures the severity of pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain ( At PACU, then every 2 hours till 24 hours)'}], 'secondaryOutcomes': [{'measure': 'Number of participants and Percentage of Drug-related side effects', 'timeFrame': '24 hours after the end of the operation', 'description': 'Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, and Postoperative nausea and vomiting (PONV)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical plexus block', 'Dexamethasone', 'Dexmedetomidine', 'Thyroidectomy'], 'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'Background: Many thyroidectomy patients suffer from postoperative pain that could delay early hospital discharge and place a significant burden on both the patient and the healthcare team. Bilateral intermediate cervical plexus block (ICPB) provides good analgesia for neck surgery, including thyroidectomy. However, the duration of a single-shot nerve block is usually short. Therefore, adjuvants are used in peripheral nerve blocks.\n\nObjectives: To compare the safety and efficacy of dexmedetomidine versus dexamethasone as adjuvants to bupivacaine in ultrasound-guided intermediate cervical plexus block in patients undergoing total thyroidectomy under general anesthesia.\n\nPatients and Methods: This is a randomized, double-blind, phase four, prospective clinical trial; carried out on 60 patients, who were candidates for total thyroidectomy under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received bilateral ICPB with isobaric bupivacaine plus dexmedetomidine, and group B, received bilateral ICPB with isobaric bupivacaine plus dexamethasone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status ≤ II\n* Age from 21 to 60 years\n* Body Mass Index (BMI) ≤ 35 kg/m2\n\nExclusion Criteria:\n\n* ASA physical status \\> II\n* Age \\< 21 years or \\> 50 years\n* BMI \\> 35 kg/m2\n* Bronchial asthma\n* Chronic obstructive pulmonary disease\n* Restrictive lung diseases\n* Sick sinus syndrome\n* Sinus bradycardia\n* Hypertension\n* Chronic hypotension\n* Ischemic heart disease\n* Coagulopathies\n* Hepatic insufficiency\n* Renal insufficiency\n* Diabetes mellitus\n* Peripheral neuropathy\n* Thyroid malignancy\n* Hyperthyroidism\n* Substernal goiter\n* Patients on beta-blockers\n* Patients using pacemakers\n* Alcohol or drug abuse\n* Allergy to the study drugs'}, 'identificationModule': {'nctId': 'NCT05793060', 'briefTitle': 'Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Damanhour Teaching Hospital'}, 'officialTitle': 'Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Ultrasound-guided Intermediate Cervical Plexus Block in Patients Undergoing Thyroidectomy', 'orgStudyIdInfo': {'id': 'DTH: 23001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (n=30)', 'description': 'Dexmedetomidine group', 'interventionNames': ['Drug: Dexmedetomidine Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (n=30)', 'description': 'Dexamethasone group', 'interventionNames': ['Drug: Dexamethasone Phosphate']}], 'interventions': [{'name': 'Dexmedetomidine Hydrochloride', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Dexmedetomidine 50 Mcg', 'armGroupLabels': ['Group A (n=30)']}, {'name': 'Dexamethasone Phosphate', 'type': 'DRUG', 'otherNames': ['Dexamethasone'], 'description': 'Dexamethasone 4 mg', 'armGroupLabels': ['Group B (n=30)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damanhūr', 'state': 'El-Beheira', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M Shaat, MD', 'role': 'CONTACT', 'email': 'ahmedshaat99@gmail.com', 'phone': '00201223482709'}], 'facility': 'Damanhour Teaching Hospital', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'centralContacts': [{'name': 'Ahmed M Shaat, MD', 'role': 'CONTACT', 'email': 'ahmedshaat99@gmail.com', 'phone': '00201223482709'}], 'overallOfficials': [{'name': 'Ahmed M Shaat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Damanhour Teaching Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour Teaching Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}