Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 10:13 AM
Study NCT ID:
NCT06061159
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2023-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2023-09-24', 'studyFirstSubmitQcDate': '2023-09-24', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the time of the loss of consciousness(LOC)', 'timeFrame': 'during anaesthetic induction', 'description': 'Modified Observers Assessment of Alertness/Sedation (MOAA/S) score of 1 or deeper within 1 minute, and maintained until the end of the 5-minute observation period.'}], 'secondaryOutcomes': [{'measure': "Modified observer's assessment of alertness／sedation（MOAA/S）scale", 'timeFrame': 'Every 1 minutes after single intravenous bolus remimazolam', 'description': '5-Subject responds readily to name spoken in a normal tone; 4 -Lethargic response of a subject to a name spoken in a normal tone; 3 -The subject responds only after a name is called loudly and repeatedly; 2 -The subject responds only after mild prodding or shaking;\n\n1 -The subject responds only after a painful trapezius squeeze; 0 -The subject does not respond to painful trapezius squeeze. MOAA/S score ≤ 1 points represent successful sedation'}, {'measure': 'BIS', 'timeFrame': 'Every 1 minutes after single intravenous bolus remimazolam', 'description': 'BIS values range from 0 to 100. A value of 0 represents the absence of brain activity, and 100 represents the awake state.\n\nBIS values between 60 to 80 represent sedation; BIS values between 40 to 60 represent adequate general anesthesia for a surgery; values less than 40 represent a deep hypnotic state.'}, {'measure': 'Recovery time', 'timeFrame': "Within up to 30 minutes after child's first eye opening in the postoperative period", 'description': "The time from discontinuation of sevoflurane to the first open eye of the children and to achieve the modified aldrete scole ≥9.\n\nthen the aldrete scole's minimum value is 0 and maximum value is 10, and higher scores mean a better or outcome.\n\nThe modified aldrete scole consists of five items. Each item is scored 0-2 yielding a total between 0 and 10."}, {'measure': 'Number of children with adverse effects', 'timeFrame': 'Up to 24 hours including preoperative, intraoperative, and postoperative periods', 'description': 'Number of children with adverse effects:\n\n１、Bradycardia and/or hypotension need for hemodynamic support; 2、Desaturation is defined as Oxygen desaturation \\<90%; 3、Nausea and vomiting; 4、Any adverse effects requiring interventions.'}, {'measure': 'Rate of Pediatric anesthesia emergence delirium', 'timeFrame': "Within up to 15-30 minutes after child's first eye opening in the postoperative period", 'description': 'The pediatric anesthesia emergence delirium scale consists of five items. Each item is scored 0-4 yielding a total between 0 and 20.\n\nThe degree of emergence delirium increased directly with the total score. pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remimazolam'], 'conditions': ['Pediatric', 'ED95', 'Sedation', 'General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '40107902', 'type': 'DERIVED', 'citation': 'Cai YH, Dong LQ, Zhong JW, Lin Z, Chen CD, Zhu LB, Lin XK, Szmuk P, Liu HC. ED50 and ED95 of remimazolam for loss of consciousness in young children: a dose-finding study for induction of anaesthesia. Br J Anaesth. 2025 Jun;134(6):1709-1716. doi: 10.1016/j.bja.2025.02.004. Epub 2025 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'Due to the incomplete development of systems and low pain thresholds in the pediatric population, good general anesthesia is required during the perioperative period to ensure the smooth progress of the surgery.Propofol is often used for anesthesia induction in clinical work, which can achieve good anesthesia effects. However, this drug has obvious injection pain and is prone to significant inhibition of blood circulation, and may even lead to adverse conditions such as respiratory depression in children. For the pediatric population, maintaining appropriate anesthesia depth and stable circulation during the induction period of general anesthesia has always been a focus of attention and research by anesthesiologists.Remimazolam besylate is a new type of water-soluble ultra short acting benzodiazepine drug that is hydrolyzed and metabolized by plasma esterase in the body, independent of liver and kidney function, and the metabolite zolam propionic acid has no pharmacological activity; Rapid onset and failure, short sedation recovery time; Has little impact on respiration and circulation; And there is no injection pain.Remazolam besylate is highly suitable for children due to its characteristics, and some studies have demonstrated the safety of intravenous injection of Remazolam besylate. However, there is limited research on its dosage exploration, which to some extent limits its clinical application in children.This study aims to explore the 95% effective dose (ED95) of single intravenous injection of remidazolam besylate in children of different age groups, providing a theoretical basis for the use of remidazolam besylate in pediatric anesthesia.', 'detailedDescription': 'This experiment was divided into three groups based on the age of the children, namely 1-3 years old, 4-6 years old, 7-12 years old, with an initial dose of 0.2mg/kg. The time of consciousness loss in the children was evaluated after injection of ramazolam besylate to determine whether sedation had been achieved. The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the ED95 of a single intravenous injection of ramazolam in children of different age groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. with American Society of Anesthesiologists (ASA) physical status I or II；\n2. aged 1-12 years；\n3. children with weight for age within the normal range；\n4. were scheduled general anesthesia surgery\n\nExclusion Criteria:\n\n1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;\n2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam;\n3. recently respiratory infection, mental disorder;\n4. other reasons that researchers hold it is not appropriate to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT06061159', 'briefTitle': 'The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction:a Randomised,Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2023-03-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1-3years old', 'description': 'single intravenous bolus remimazolam about 5min before general anesthesia induction', 'interventionNames': ['Drug: Remimazolam besylate']}, {'type': 'EXPERIMENTAL', 'label': '3-6years old', 'description': 'single intravenous bolus remimazolam about 5min before general anesthesia induction', 'interventionNames': ['Drug: Remimazolam besylate']}, {'type': 'EXPERIMENTAL', 'label': '6-12years old', 'description': 'single intravenous bolus remimazolam about 5min before general anesthesia induction', 'interventionNames': ['Drug: Remimazolam besylate']}], 'interventions': [{'name': 'Remimazolam besylate', 'type': 'DRUG', 'otherNames': ['single intravenous bolus remimazolam according to biased coin design'], 'description': 'initial dose is 0.2mg/kg；adjust dosage is 0.05mg/kg', 'armGroupLabels': ['6-12years old']}, {'name': 'Remimazolam besylate', 'type': 'DRUG', 'otherNames': ['single intravenous bolus remimazolam according to biased coin design'], 'description': 'initial dose is based on the findings from the school-age group；adjust dosage is 0.05mg/kg', 'armGroupLabels': ['1-3years old', '3-6years old']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University", 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Huacheng Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Wenzhou Medical University'}, {'name': 'Yuhang Cai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Wenzhou Medical University'}, {'name': 'Leqi Dong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}