Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-04 @ 3:30 PM
Study NCT ID:
NCT04200235
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Dexmedetomidine hydrochloride nasal spray compared with placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-07', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK Cmax', 'timeFrame': '0 to 1 hour after administration', 'description': 'Maximum blood concentration (Cmax)'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects who parent-child separation successful', 'timeFrame': '0 minute to 45 minutes after administration: every 15 minutes after administration', 'description': 'The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success defined as a scale of 3 or 4 per item.'}, {'measure': 'Proportion of subjects who the Ramsay score is satisfactory at least once', 'timeFrame': '0 minute to 45 minutes after administration: every 5 minutes after administration', 'description': 'Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 2, 3, or 4;'}, {'measure': 'Proportion of subjects who the UMSS Scale is satisfactory at least once', 'timeFrame': '0 minute to 45 minutes after administration: every 5 minutes after administration', 'description': 'Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction defined as a scale of 3, 4, 5, or 6;'}, {'measure': 'Total consumption of propofol(mg) during general anesthesia', 'timeFrame': 'From the beginning of anesthesia to the end of surgical operation up to 4 hours', 'description': 'Total consumption of propofol(mg) during general anesthesia'}, {'measure': 'Total consumption of opioid analgesic(μg) during general anesthesia', 'timeFrame': 'From the beginning of anesthesia to the end of surgical operation up to 4 hours', 'description': 'Total consumption of opioid analgesic(μg) during general anesthesia'}, {'measure': 'Time of anesthesia awakening', 'timeFrame': 'Up to 4 hours after the end of surgical operation', 'description': 'Time of anesthesia awakening'}, {'measure': 'Proportion of subjects with postoperative agitation', 'timeFrame': 'Up to 4 hours after the end of surgical operation', 'description': 'Proportion of subjects with postoperative agitation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preoperative Sedation']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Male or female\n3. Subjects requiring elective general anesthesia surgery\n4. Conform to the ASA Physical Status Classification\n5. Meet the weight standard\n\nExclusion Criteria:\n\n1. Not suitable for nasal spray\n2. Pediatric populations requiring special care or court/social welfare supervision\n3. Subjects who had been under general anesthesia were randomized\n4. Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy\n5. Subjects with previous abnormal behavior after medication\n6. Subjects with cardiovascular disease\n7. Clinically significant abnormal clinical laboratory test value\n8. Subjects whose hemoglobin is below the lower limit of normal\n9. Subjects who have either an adrenergic receptor agonist or an antagonist were randomized\n10. Participated in clinical trials of other drugs before screening (accepted experimental drugs)\n11. A history or possibility of difficult airway\n12. History of hypersensitivity to drug ingredients or components\n13. Other circumstances that the investigator judged inappropriate for participation in this clinical trial'}, 'identificationModule': {'nctId': 'NCT04200235', 'briefTitle': 'A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children', 'orgStudyIdInfo': {'id': 'HR0171401-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High weight group', 'description': 'High weight group', 'interventionNames': ['Drug: Dexmedetomidine hydrochloride nasal spray', 'Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.']}, {'type': 'EXPERIMENTAL', 'label': 'Low weight group', 'description': 'Low weight group', 'interventionNames': ['Drug: Dexmedetomidine hydrochloride nasal spray', 'Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.']}], 'interventions': [{'name': 'Dexmedetomidine hydrochloride nasal spray', 'type': 'DRUG', 'description': 'In the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray.\n\nIn the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray.', 'armGroupLabels': ['High weight group', 'Low weight group']}, {'name': 'Dexmedetomidine hydrochloride nasal spray blank preparation.', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'In the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.\n\nIn the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.', 'armGroupLabels': ['High weight group', 'Low weight group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Beijing children's hospital, capital medical university", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}