Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:17 AM
Study NCT ID:
NCT07450495
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Concentrations of Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017043', 'term': 'Chalazion'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAED score', 'timeFrame': 'Within 30 minutes after recovery', 'description': 'Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale ranges from 0 to 20, with higher scores indicating more severe emergence delirium (worse outcome).'}], 'secondaryOutcomes': [{'measure': 'Induction time', 'timeFrame': 'Immediately after anesthesia induction', 'description': 'Time from face mask placement to loss of eyelash reflex, measured in seconds.'}, {'measure': 'Recovery time', 'timeFrame': 'Immediately after anesthesia discontinuation', 'description': 'Time from discontinuation of sevoflurane to full recovery of consciousness, measured in minutes.'}, {'measure': 'Minimum alveolar concentration (MAC)', 'timeFrame': 'Perioperatively', 'description': 'Minimum alveolar concentration (MAC) values recorded during anesthesia maintenance.'}, {'measure': 'Respiratory depression', 'timeFrame': 'Perioperatively', 'description': 'Incidence of respiratory depression recorded during the perioperative period.'}, {'measure': 'Hypoxia', 'timeFrame': 'Perioperatively', 'description': 'Incidence of hypoxia recorded during the perioperative period.'}, {'measure': 'Cough', 'timeFrame': 'Perioperatively', 'description': 'Incidence of cough recorded during the perioperative period.'}, {'measure': 'Nausea and vomiting', 'timeFrame': 'Immediately after anesthesia until discharge', 'description': 'Incidence of nausea and vomiting recorded during the postoperative recovery period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chalazion']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to compare the effectiveness and safety of 6% versus 8% sevoflurane inhalation induction in pediatric patients undergoing minor ophthalmic surgery. The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes include hemodynamic parameters, induction time, recovery time, and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1 to 6 years (12-72 months)\n* Scheduled to undergo minor ophthalmic surgery (e.g., chalazion excision) under general anesthesia\n* American Society of Anesthesiologists (ASA) physical status I\n* Assessed as suitable for inhalation anesthesia by anesthesiologists\n* Written informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n* ASA physical status II or higher\n* Known hepatic or renal dysfunction\n* Congenital heart disease\n* History of malignant hyperthermia\n* Known allergy to sevoflurane\n* History of asthma or severe respiratory disease\n* Upper respiratory tract infection within the past 4 weeks\n* Anticipated difficult airway\n* Refusal of participation by parents or legal guardians'}, 'identificationModule': {'nctId': 'NCT07450495', 'acronym': 'SEVO-PED', 'briefTitle': 'Effect of Different Concentrations of Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong'}, 'officialTitle': 'Effectiveness and Safety of 6% Versus 8% Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Minor Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EC20240514(3)-P38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane 8% Group', 'description': 'Participants received 8% sevoflurane inhalation for anesthesia induction via face mask.', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Sevoflurane 6% Group', 'description': 'Participants received 6% sevoflurane inhalation for anesthesia induction via face mask.', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevorane,Sevorane,Ultane'], 'description': 'Sevoflurane inhalation anesthesia was used for induction and maintenance of general anesthesia in pediatric patients undergoing minor ophthalmic surgery.', 'armGroupLabels': ['Sevoflurane 6% Group', 'Sevoflurane 8% Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '515041', 'city': 'Shantou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Laiwen Lv, MSc.', 'role': 'CONTACT', 'email': 'llw@jsiec.org', 'phone': '13750440405'}], 'facility': 'Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}], 'centralContacts': [{'name': 'Laiwen Lv, MSc.', 'role': 'CONTACT', 'email': 'llw@jsiec.org', 'phone': '13750440405'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Laiwen Lv', 'investigatorAffiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong'}}}}