Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-04-05 @ 10:09 AM
Study NCT ID:
NCT02757495
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2016-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Side-effect-bradycardia', 'timeFrame': 'intraoperatively and 24 hour postoperatively', 'description': 'a heart rate less than 60 beats/min'}, {'measure': 'Side-effect-hypotension', 'timeFrame': 'intraoperatively and 24 hour postoperatively', 'description': 'Hypotension will be defined as a blood pressure below the 5th percentile for age and height'}, {'measure': 'Side-effect-respiratory depression', 'timeFrame': 'intraoperatively and 24 hour postoperatively', 'description': 'Respiratory depression will be defined as unable to maintain oxygen saturation of ≥ 95%.'}, {'measure': 'Side-effect-urinary retention', 'timeFrame': 'intraoperatively and 24 hour postoperatively', 'description': 'A urine output of less than 1 ml/kg/hr with a full bladder'}], 'primaryOutcomes': [{'measure': 'Degree of Emergence Agitation will be evaluated-initial', 'timeFrame': 'upon awakening', 'description': 'using the pediatric anesthesia emergence delirium scale (PAED), Patients will be considered agitated if they had a score of 16/20 or higher'}], 'secondaryOutcomes': [{'measure': 'Incidence of emergence agitation at different time interval after surgery', 'timeFrame': '10 min ,20 min , 30 min and 60 min after surgery', 'description': 'using the pediatric anesthesia emergence delirium scale (PAED), Patients will be considered agitated if they had a score of 16/20 or higher'}, {'measure': 'Emergence time', 'timeFrame': 'immediately postoperative', 'description': 'the time from the cessation of sevoflurane to the eye-opening will be noted.'}, {'measure': 'Postoperative pain will be assessed, pain score will be observed and recorded at different time interval after surgery', 'timeFrame': 'immediately postoperative and every 4 hours in the first 24 hours', 'description': 'Pain will be assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score.\n\nEach category is scored on the 0-2 scale which results in a total score of 0-10.\n\nAssessment of Behavioural Score:\n\n0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain Patients with pain score ≥4 will be given rescue analgesia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sevoflurane emergence agitation', 'caudal dexmedetomidine'], 'conditions': ['Delayed Emergence From Anesthesia']}, 'descriptionModule': {'briefSummary': 'Emergence agitation (EA) is common phenomenon in pediatric patients undergoing general anesthesia by inhalation agents. The incidence of EA was reported to range from 18% to 80%. Sevoflurane now is the inhalational anesthetic agent of choice for pediatrics, Different strategies have been suggested to decrease the incidence and severity of EA. No gold standard technique for treating EA after sevoflurane anesthesia is currently available. The main question is can caudal dexmedetomidine be used for this purpose?', 'detailedDescription': 'The purpose of this prospective comparative randomized clinical study will be to compare the effects of caudal dexmedetomidine on EA in children undergoing lower abdominal operations under general sevoflurane anesthesia. In addition, characteristics of anesthesia recovery and incidence of adverse effects will be compare. A total of (48) children aged 1-5 years old, The American society of Anesthesiologists (ASA) physical status classification system between I-II of both sex who will be enrolled from April 2016 to April 2017 undergoing for lower abdominal surgeries will be included in the study. Patients will be randomized by computer-generated random numbers in a double blinded fashion to get enrolled into 2 equal groups: Group BD patients (n = 24) will be received single dose caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 24) will be received single dose caudal epidural analgesia with bupivacaine only. The dexmedetomidine used for this study will be prepared in a 1 ml syringe wrapped in aluminum foil by an investigator who will not be involved in the anesthesia process and another 1 ml syringe filled with saline will be prepared too.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1-5 years old,\n* The American society of Anesthesiologists (ASA) physical status classification system between I-II of both sex who will be enrolled from March 2015 to March 2016 undergoing for lower abdominal surgeries, e.g., hernia and perineal surgeries, e.g., undescended testis and hypospadius will be included in the study.\n\nExclusion Criteria:\n\n* mental retardation, developmental delay, known allergy to any of the study drugs, congenital anomalies of spine, neurological or psychiatric illness that may be associated with improper communication, any signs of local infection in the sacrum region, any kind of cardiac conduction disorder, bleeding disorders, any previous cardiovascular disease and parental refusal.'}, 'identificationModule': {'nctId': 'NCT02757495', 'briefTitle': 'Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children', 'orgStudyIdInfo': {'id': 'gkamhawy'}, 'secondaryIdInfos': [{'id': 'Tarek F. Tammam', 'type': 'OTHER', 'domain': 'Suez canal university'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Traditional', 'description': 'This will utilize the traditional method of performance of single dose caudal epidural block'}, {'type': 'EXPERIMENTAL', 'label': 'Caudal dexmedetomidine', 'description': 'In this arm, single dose caudal epidural injection will be done patients in this arm will be given dexmedetomidine (precedex 100 µg/mL parenteral preparation (Hospira ® ) 2 µg/kg in 1 ml/kg bupivacaine 0.25%', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Single dose caudal epidural injection will be done using 25 G needle. patients of Group BD will be given dexmedetomidine (precedex 100 µg/mL parenteral preparation (Hospira ® ) 2 µg/kg in 1 ml/kg bupivacaine 0.25%,', 'armGroupLabels': ['Caudal dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41522', 'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez canal University hospital', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'overallOfficials': [{'name': 'Ghada A. Kamhawy, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Suez Canal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia,faculty of medicine, suez canal university', 'investigatorFullName': 'Ghada A.Kamhawy', 'investigatorAffiliation': 'Suez Canal University'}}}}