Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06170918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose of Remimazolam in Children for Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The initial dose is 0.4mg/kg and the dose interval is 0.2mg/kg'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'half effective dose for intubation', 'timeFrame': 'from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes', 'description': 'half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl'}, {'measure': 'cardiovascular response to tracheal intubation', 'timeFrame': 'from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes', 'description': 'cardiovascular response is defined as increase of blood pressure or heart rate higher than 20% of the baseline value by 3 minutes after intubation'}], 'secondaryOutcomes': [{'measure': 'the time to loss of consciousness', 'timeFrame': 'from injection of remimazolam to loss of consciousness, at an average of 3 minutes'}, {'measure': 'incidence of adverse events', 'timeFrame': 'from injection of remimazolam to loss of consciousness, at an average of 3 minutes', 'description': 'adverse events include bradycardia, hypotension, hypoxemia, and injection pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anesthesia induction', 'remimazolam', 'tracheal intubation', 'median effective dose'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '36843931', 'type': 'BACKGROUND', 'citation': 'Fang YB, Wang CY, Gao YQ, Cai YH, Chen J, Zhang XL, Dong LQ, Shang-Guan WN, Liu HC. The safety and efficacy of remimazolam tosylate for induction and maintenance of general anesthesia in pediatric patients undergoing elective surgery: Study protocol for a multicenter, randomized, single-blind, positive-controlled clinical trial. Front Pharmacol. 2023 Feb 10;14:1090608. doi: 10.3389/fphar.2023.1090608. eCollection 2023.'}, {'pmid': '37373624', 'type': 'BACKGROUND', 'citation': 'Kimoto Y, Hirano T, Kuratani N, Cavanaugh D, Mason KP. Remimazolam as an Adjunct to General Anesthesia in Children: Adverse Events and Outcomes in a Large Cohort of 418 Cases. J Clin Med. 2023 Jun 8;12(12):3930. doi: 10.3390/jcm12123930.'}]}, 'descriptionModule': {'briefSummary': 'Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl in pediatric patients is still unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age from 3 to 12 years old\n* patients scheduled for surgery under general anesthesia\n* Body mass index in the range of 5% -95% of the same age group\n* Consent was obtained from the patient and the family members, and an informed consent form was signed\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists status ≥3\n* patients who cannot cooperate with intravenous anesthesia induction\n* patients with risk of difficult airway\n* patients who are allergic to benzodiazepines\n* patients with neurological dysfunction\n* Participate involved in other clinical investigators within 3 months'}, 'identificationModule': {'nctId': 'NCT06170918', 'acronym': 'DRIP', 'briefTitle': 'Dose of Remimazolam in Children for Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Half Effective Dose of Remimazolam to Prevent Cardiovascular Response to Tracheal Intubation When Combined With Fentanyl', 'orgStudyIdInfo': {'id': 'XJH-A-20231120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'remimazolam', 'description': 'Remimazolam is given for anesthesia induction. The initial dosage is 0.4mg/kg, and the interval dosage is 0.02mg/kg.', 'interventionNames': ['Drug: Remimazolam']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'otherNames': ['remimazolam besylate'], 'description': 'remimazolam is given intravenously', 'armGroupLabels': ['remimazolam']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhihong LU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}