Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
Study NCT ID:
NCT06761092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-22
First Post:
2024-12-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'pediatric preschool, age 2-6 years old, undergoing elective general surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-02-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-18', 'studyFirstSubmitDate': '2024-12-29', 'studyFirstSubmitQcDate': '2025-01-04', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduce post anesthesia delirium incidence', 'timeFrame': '120 minutes (after extubation till discharge from recovery room)', 'description': 'After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nebulized', 'dexmedetomidine', 'post anesthesia delirium', 'sevoflurane', 'preschool'], 'conditions': ['Emergence Delirium', 'Delirium - Postoperative']}, 'descriptionModule': {'briefSummary': 'Analyzing the effectiveness of nebulized dexmedetomidine 2 mcg/kg in reducing the incidence of post-anesthesia delirium in preschool children undergoing elective surgery with sevoflurane inhalation general anesthesia.\n\nResearchers will compare nebulized Dexmedetomidine to a placebo (a look-alike substance that contains no drug) to see if the drug can reduce post anesthesia delirium incidence.', 'detailedDescription': 'participant will : Nebulized with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, is administered before the induction of anesthesia in the reception area.\n\nAfter the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) in the recovery room.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients aged 2 to 6 years old.\n* Planned general anesthesia using inhalation sevoflurane with endotracheal tube techniques\n* Parents agree to participate in the study\n\nExclusion Criteria:\n\n* Pediatric patients with \\> ASA II.\n* Difficult airway management.\n* Emergency surgery.\n* Congenital abnormalities of vital organs.\n* Malnutrition\n* history or diagnosed with mental or cognitive disorders.\n* History of upper respiratory infection within 2 weeks before the procedure.\n* History of allergy to dexmedetomidine.\n* Surgery duration estimation exceeding 180 minutes.\n* Parents refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT06761092', 'briefTitle': 'Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'Udayana University'}, 'officialTitle': 'Nebulized Dexmedetomidine to Reduce Post-Anesthesia Delirium of Sevoflurane in Preschool Children Undergoing Elective Surgery', 'orgStudyIdInfo': {'id': 'DP.04.03/D.XVII.2.2.2/76407/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children', 'description': 'Nebulization with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, administered before the induction of anesthesia in the reception area.\n\nAfter the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) at 15, 30, 60, and 120 minutes post-surgery in the recovery room.', 'interventionNames': ['Drug: Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nebulized Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children', 'description': 'Nebulization with normal saline 0.9% 3ml, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) at 15, 30, 60, and 120 minutes post-surgery in the recovery room.', 'interventionNames': ['Procedure: Nebulized 0.9% Normal Saline']}], 'interventions': [{'name': 'Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children', 'type': 'DRUG', 'description': 'Nebulization with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, administered before the induction of anesthesia in the reception area.\n\nAfter the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room', 'armGroupLabels': ['Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children']}, {'name': 'Nebulized 0.9% Normal Saline', 'type': 'PROCEDURE', 'description': 'Nebulization with normal saline 0.9% 3 ml, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room', 'armGroupLabels': ['Nebulized Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denpasar', 'state': 'Bali', 'country': 'Indonesia', 'facility': 'Anesthesiology and Intensive Therapy Udayana University', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Udayana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Jimmy Wongkar', 'investigatorAffiliation': 'Udayana University'}}}}