Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT04331418
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2020-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2020-03-27', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of recovery of the studied patients', 'timeFrame': 'in immediate recovery from aneasthesia at postaneathetic care unit up to 2 hours', 'description': 'quality of recovery of the studied patients using modified objective pain score'}, {'measure': 'quality of recovery of the studied patients', 'timeFrame': 'from discharge from PACU up to 6 hours in the surgical ward', 'description': 'change in quality of recovery of the studied patients using modified objective pain score'}], 'secondaryOutcomes': [{'measure': 'concentration of required postoperative analgesic', 'timeFrame': 'in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit', 'description': 'concentration of postoperative analgesic'}, {'measure': 'concentration of required postoperative analgesic', 'timeFrame': 'from discharge from PACU up to 6 hours in the surgical ward', 'description': 'concentration of required postoperative analgesic'}, {'measure': 'concentration of required postoperative sedation', 'timeFrame': 'in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit', 'description': 'concentration of required postoperative sedation'}, {'measure': 'concentration of required postoperative sedation', 'timeFrame': 'from discharge from PACU up to 6 hours in the surgical ward', 'description': 'concentration of required postoperative sedation'}, {'measure': 'number of patients developed perioperative complications.', 'timeFrame': 'in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit', 'description': 'number of patients developed perioperative complications'}, {'measure': 'number of patients developed perioperative complications.', 'timeFrame': 'from discharge from PACU up to 6 hours in the surgical ward', 'description': 'number of patients developed perioperative complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine Infusion', 'Pediatric', 'Hypospadias Repair Surgery']}, 'descriptionModule': {'briefSummary': 'Pain is one of the most misunderstood, underdiagnosed, and untreated medical problems, particularly in children. New Joint Commission on Accreditation of Health Care Organization regards pain as fifth vital sign and requires caregivers to regularly assess pain. Inadequate pain relief during childhood may have long-term negative effects including harmful neuroendocrine responses disrupted eating and sleep cycles and increased pain perception during subsequent painful experiences. Also, postoperative pain can result in an uncooperative and restless child. Hence, it is preferable to prevent the onset of pain rather than to relieve its existence.\n\nVarious multimodal techniques have been designed for pediatric pain relief. These include both systemic and regional analgesia. The most commonly used regional technique is caudal epidural block. Advantages of the caudal block are smoother recovery with less distress behavior, early ambulation, decreased the risk of chest infections, decreased postoperative analgesic requirements, and early discharge.\n\nIn our culture; considerable number of parents still refuses caudal anesthesia fearing from the rare neurological sequelae may occur. This the motive for searching for parenteral surrogate gives clear headed recovery resembles regional analgesia.\n\nDexmedetomidine is an alpha 2 agonist which has sedative, analgesic, and opioid-sparing effect. It prolongs the duration of analgesia by its local vasoconstrictive effect and by increasing the potassium conductance in A-delta and C-fibers.\n\nIt also exerts its analgesic action centrally via systemic absorption or by diffusion into the cerebrospinal fluid and reaches alpha 2 receptors in the superficial laminae of the spinal cord and brainstem or indirectly activating spinal cholinergic neurons. The sedative effects of dexmedetomidine are mostly due to stimulation of the alpha 2 adrenoceptor in the locus coeruleus'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. male children\n2. american society of aneasthesia physical status grade I \\&II\n3. patients aged from 2 years to 12 years\n4. patients will undergoing hypospadias repair surgery\n\nExclusion Criteria:\n\n1. history or evidence of infection at the back\n2. allergy to the study drugs\n3. bleeding/coagulation disorder\n4. developmental delay\n5. septic patients\n6. neurological or spinal diseases.'}, 'identificationModule': {'nctId': 'NCT04331418', 'briefTitle': 'Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery', 'orgStudyIdInfo': {'id': 'precedex infusion in pediatric'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'On arrival to operating room, Noninvasive monitors, such as electrocardiography, noninvasive blood pressure (NIBP), oxygen saturation (SpO2), will be attached and baseline parameters such as heart rate, mean arterial pressure, and peripheral oxygen saturation will be recorded .\n\nGeneral anesthesia will be induced with O2/sevo (FiO2 = 1 /sevoflurane 8% MAC), cis-atracurium 0.1 mg/kg iv, +/- fentanyl 1 mcg/kg iv. Trachea will be intubated with an appropriate sized, endotracheal tube and maintenance of anesthesia by O2/Air (FiO2 = 0.4), sevoflurane 2% MAC.\n\nDexamethasone 0.15 mg/kg iv will be given as PONV prophylaxis. Increments of fentanyl 0.5 mcg/kg iv and cis-atracurium 0.03 mg/kg iv will be given according to hemodynamics and capnography.'}, {'type': 'EXPERIMENTAL', 'label': 'caudal group', 'description': 'After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.', 'interventionNames': ['Procedure: caudal block']}, {'type': 'EXPERIMENTAL', 'label': 'dexmetomidine group', 'description': 'Children in this group will be received (1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr) with a suggested maximum dose of 2 mcg/kg.of dexmedetomidine is available in a 100 mcg/mL concentration in a 2 mL preservative-free vial. It may be prepared as a 2 to 4 mcg/mL solution using normal saline', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': '1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr', 'armGroupLabels': ['dexmetomidine group']}, {'name': 'caudal block', 'type': 'PROCEDURE', 'description': 'After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.', 'armGroupLabels': ['caudal group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Ahmed Abdelrahman', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amany Faheem', 'investigatorAffiliation': 'Tanta University'}}}}