Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT04621305
Status:
UNKNOWN
Last Update Posted:
2021-01-13
First Post:
2020-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of emergence delirium', 'timeFrame': 'Within up to 30 minutes after operation', 'description': 'The pediatric anesthesia emergence delirium scale consists of four 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 ≥10 at any time indicates presence of emergence delirium.'}], 'secondaryOutcomes': [{'measure': 'End tidal sevoflurane concentration', 'timeFrame': 'During the preoperative period', 'description': 'End tidal sevoflurane concentration at BIS 40-60'}, {'measure': 'Pediatric anesthesia emergence delirium', 'timeFrame': 'Within up to 30 minutes after operation', 'description': 'The pediatric anesthesia emergence delirium scale consists of four 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.'}, {'measure': 'FLACC scale', 'timeFrame': 'Within up to 30 minutes after operation', 'description': 'The FLACC scale consists of fIve items. Each item is scored 0-2 yielding a total between 0 and 10.\n\nThe degree of pain increased directly with the total score.'}, {'measure': 'Ramsay Sedation Scale score', 'timeFrame': 'Within up to 30 minutes after operation', 'description': '1. \\- The patient is anxious and agitated, restless, or both;\n2. \\- The patient is cooperative, oriented, and tranquil;\n3. \\- The patient responds to commands only;\n4. \\- The patient is asleep and shows a brisk response to a light glabellar tap or loud auditory stimulus;\n5. \\- The patient is asleep and shows a slow response to a light glabellar tap or loud auditory stimulus;\n6. \\- The patient is asleep and shows no response to a light glabellar tap or loud auditory stimulus.\n\nThe degree of sedation increased directly with the total score.'}, {'measure': 'Recovery times', 'timeFrame': 'Up to 30 minutes after operation', 'description': 'The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete≥9'}, {'measure': 'Number of children with adverse effects', 'timeFrame': 'Up to 24 hours including intraoperative, and postoperative periods', 'description': 'Number of children with adverse effects\n\nBradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation \\<90% Any adverse effects requiring interventions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remimazolam', 'emergence delirium'], 'conditions': ['Emergence Delirium']}, 'descriptionModule': {'briefSummary': "Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The use of sevoflurane has been identified as one of the most important risk factors. In the investigators' study，the researchers conducted the current study to investigate whether remimazolam can reduce incidence of ED.", 'detailedDescription': 'One hundred twenty children aged 1-6 years old were randomly allocated into three equal groups. Anesthesia is induced with propofol，fentanyl and rocuronium. In group P (Placebo group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. In group B (Bolus group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered. In group C (continuous infusion group), anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. Maintain BIS values in the range of 40-60. Recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. -with American Society of Anesthesiologists (ASA) physical status I or II；\n2. -aged 1-6 years；\n3. -children with weight for age within the normal range；\n4. -were scheduled laparoscopic surgery by sevoflurane anesthesia.\n\nExclusion Criteria:\n\n1. -children who had Abnormal liver and kidney function,Cardiovascular or endocrine dysfunction;\n2. -allergy or hypersensitive reaction to remimazolam;\n3. -with any organ dysfunction;\n4. -recently respiratory infection, mental disorder;\n5. -other reasons that researchers hold it is not appropriate to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT04621305', 'briefTitle': 'Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia: a Double-blinded Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2020-03-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'group P (Placebo group)', 'description': 'Patients were assigned to group P (Placebo group) using a computer-generated random number table', 'interventionNames': ['Other: normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'group B (Bolus group)', 'description': 'Patients were assigned to group B (Bolus group) using a computer-generated random number table', 'interventionNames': ['Drug: Bolus Remimazolam']}, {'type': 'EXPERIMENTAL', 'label': 'group C (continuous infusion group)', 'description': 'Patients were assigned to group C (continuous infusion group) using a computer-generated random number table', 'interventionNames': ['Drug: Continuous Infusion Remimazolam']}], 'interventions': [{'name': 'normal saline', 'type': 'OTHER', 'otherNames': ['Placebo group'], 'description': 'Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered', 'armGroupLabels': ['group P (Placebo group)']}, {'name': 'Bolus Remimazolam', 'type': 'DRUG', 'otherNames': ['Bolus group'], 'description': 'Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered.', 'armGroupLabels': ['group B (Bolus group)']}, {'name': 'Continuous Infusion Remimazolam', 'type': 'DRUG', 'otherNames': ['Continuous infusion group'], 'description': 'Anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered.', 'armGroupLabels': ['group C (continuous infusion group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huacheng Liu', 'role': 'CONTACT', 'email': 'huachengliu@163.com', 'phone': '13957770577'}, {'name': 'Yuhang Cai', 'role': 'CONTACT', 'email': '838097626@qq.com', 'phone': '18815091585'}], 'facility': "The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University", 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Huacheng Liu', 'role': 'CONTACT', 'email': 'huachengliu@163.com', 'phone': '18957755138'}, {'name': 'Yuhang Cai', 'role': 'CONTACT', 'email': '838097626@qq.com', 'phone': '18815091585'}], '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}