Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-11 @ 4:30 PM
Study NCT ID:
NCT05321160
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2022-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Sedation Effect of Esketamine and Sevoflurane for Pediatric Ophthalmological Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-04-02', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of respiratory depression', 'timeFrame': 'duration from the time patient received induction to the time of leaving to the ward, average 1 hour', 'description': 'respiratory rate \\<12 times per min or weak chest undulation'}, {'measure': 'the incidence of desaturation', 'timeFrame': 'duration from the time patient received induction to the time of leaving to the ward, average 1 hour', 'description': 'the incidence of oxygen saturation below 95% caused by anesthetic agent.'}, {'measure': 'the incidence of hypotension', 'timeFrame': 'duration from the time patient received induction to the end of the anesthesia, average 15 minutes.', 'description': 'the incidence of systolic blood pressure\\< 30% of basal systolic blood pressure and lasted \\>5 minutes.'}, {'measure': 'the incidence of hypertension', 'timeFrame': 'duration from the time patient received induction to the end of the anesthesia, average 15 minutes.', 'description': 'the incidence of systolic blood pressure \\> 30% of basal systolic blood pressure'}, {'measure': 'the incidence of tachycardia', 'timeFrame': 'duration from the time patient received induction to the end of the anesthesia, average 15 minutes.', 'description': 'the incidence of heart rate increase over 30% of pre-induction and\\>120 beats per minute.'}, {'measure': 'the incidence of bradycardia', 'timeFrame': 'duration from the time patient received induction to the end of the anesthesia, average 15 minutes.', 'description': 'the incidence of heart rate less than 60 beats per minute'}, {'measure': 'the incidence of emergence agitation', 'timeFrame': 'duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes', 'description': 'the incidence of emergence agitation'}], 'secondaryOutcomes': [{'measure': 'length of stay in the post-anesthesia care unit', 'timeFrame': 'duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes', 'description': 'the time of patients staying in post-anesthesia care unit'}, {'measure': 'CPS score', 'timeFrame': 'scores at the time point of 1 minutes after extubation', 'description': 'The Cole 5-point scale CPS) score included five behaviors: 1=sleeping; 1=awake,calm;3=irritable, crying;4=inconsolable crying; 5=severe restlessness, disorientation.'}, {'measure': 'intraocular pressure', 'timeFrame': 'the time after intubation and topical anesthesia within 1 minute', 'description': 'intraocular pressure after induction'}, {'measure': 'diastolic pressure', 'timeFrame': '1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation', 'description': 'diastolic pressure'}, {'measure': 'systolic pressure', 'timeFrame': '1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation', 'description': 'systolic pressure'}, {'measure': 'heart rate', 'timeFrame': '1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation', 'description': 'heart rate'}, {'measure': 'extubation time', 'timeFrame': 'duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes', 'description': 'extubation time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adverse event', 'sevoflurane', 'esketamine'], 'conditions': ['Adverse Event']}, 'referencesModule': {'references': [{'pmid': '20683333', 'type': 'BACKGROUND', 'citation': 'Liao R, Li JY, Liu GY. Comparison of sevoflurane volatile induction/maintenance anaesthesia and propofol-remifentanil total intravenous anaesthesia for rigid bronchoscopy under spontaneous breathing for tracheal/bronchial foreign body removal in children. Eur J Anaesthesiol. 2010 Nov;27(11):930-4. doi: 10.1097/EJA.0b013e32833d69ad.'}, {'pmid': '10886700', 'type': 'BACKGROUND', 'citation': 'Cravero J, Surgenor S, Whalen K. Emergence agitation in paediatric patients after sevoflurane anaesthesia and no surgery: a comparison with halothane. Paediatr Anaesth. 2000;10(4):419-24. doi: 10.1046/j.1460-9592.2000.00560.x.'}, {'pmid': '8895263', 'type': 'BACKGROUND', 'citation': 'Welborn LG, Hannallah RS, Norden JM, Ruttimann UE, Callan CM. Comparison of emergence and recovery characteristics of sevoflurane, desflurane, and halothane in pediatric ambulatory patients. Anesth Analg. 1996 Nov;83(5):917-20. doi: 10.1097/00000539-199611000-00005.'}, {'pmid': '3970799', 'type': 'BACKGROUND', 'citation': 'White PF, Schuttler J, Shafer A, Stanski DR, Horai Y, Trevor AJ. Comparative pharmacology of the ketamine isomers. Studies in volunteers. Br J Anaesth. 1985 Feb;57(2):197-203. doi: 10.1093/bja/57.2.197.'}, {'pmid': '26410354', 'type': 'BACKGROUND', 'citation': 'Patrizi A, Picard N, Simon AJ, Gunner G, Centofante E, Andrews NA, Fagiolini M. Chronic Administration of the N-Methyl-D-Aspartate Receptor Antagonist Ketamine Improves Rett Syndrome Phenotype. Biol Psychiatry. 2016 May 1;79(9):755-764. doi: 10.1016/j.biopsych.2015.08.018. Epub 2015 Aug 24.'}, {'pmid': '21210891', 'type': 'BACKGROUND', 'citation': 'Eich C, Verhagen-Henning S, Roessler M, Cremer F, Cremer S, Strack M, Russo SG. Low-dose S-ketamine added to propofol anesthesia for magnetic resonance imaging in children is safe and ensures faster recovery--a prospective evaluation. Paediatr Anaesth. 2011 Feb;21(2):176-8. doi: 10.1111/j.1460-9592.2010.03489.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Emergence agitation is the most common reason for post-anesthesia care unit delay. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been successfully used for keeping spontaneous breathing without tracheal intubation. However, sevoflurane may cause emergence agitation as the incidence varied from 10%-80%. Although there are many sedative agents to reduce its incidence, such as propofol, midazolam, a2 adrenergic receptor agonists and ketamine, the efficacy remains limited.\n\nKetamine, a neuroleptic anesthetic agent, contains two optical isomers, s(+)-ketamine (esketamine) and R(-)-ketamine. Esketamine is a right-handed split of ketamine, which has enhanced analgesic potency and lower incidence of psychotropic side effects compared to ketamine. It stimulate breathing due to N-Methyl-D-Aspartate receptor blockade, and could even effectively countered remifentanil-induced respiratory depression. The investigators compared the effectiveness of esketamine and sevoflurane in reducing the incidence of emergence agitation after painless ophthalmological procedure in pediatric patients.', 'detailedDescription': 'Ophthalmological procedure such as suture remove, intraocular pressure (IOP) measurement, slit-lamp and fundoscopy are most frequently performed in operation with minor surgical stimulus, and the the duration of surgery is very short. Several anesthestic agents are available,but it is hard to balance short effect and fast rotation in post-anesthesia care unit. Emergence agitation is the most common reason for post-anesthesia care unit delay. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been successfully used for keeping spontaneous breathing without tracheal intubation. However, sevoflurane may cause emergence agitation as the incidence varied from 10%-80%. Although there are many sedative agents to reduce its incidence, such as propofol, midazolam, a2 adrenergic receptor agonists and ketamine, the efficacy remains limited.\n\nKetamine, a neuroleptic anesthetic agent, contains two optical isomers, s(+)-ketamine (esketamine) and R(-)-ketamine. Esketamine is a right-handed split of ketamine, which has enhanced analgesic potency and lower incidence of psychotropic side effects compared to ketamine. It stimulate breathing due to N-Methyl-D-Aspartate receptor blockade, and could even effectively countered remifentanil-induced respiratory depression. Additionally, several studies have reported ketamine could reduced agitation, but there is no study about esketamine on emergence agitation. The investigators compared the effectiveness of esketamine and sevoflurane in reducing the incidence of emergence agitation after painless ophthalmological procedure in pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status 1-2\n* required to remove the stitches by microscope after corneal surgeries\n\nExclusion Criteria:\n\n* psychiatric disorders\n* cardiovascular disorders\n* glaucoma\n* contraindications to nasal intubation'}, 'identificationModule': {'nctId': 'NCT05321160', 'briefTitle': 'Comparison of the Sedation Effect of Esketamine and Sevoflurane for Pediatric Ophthalmological Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Eye & ENT Hospital of Fudan University'}, 'officialTitle': 'Comparison of Esketamine Versus Sevoflurane Add to Dexmedetomidine-based Sedation for Minor Ophthalmology Procedure in Children: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'EA and esketamine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group E', 'description': '1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 0.25mg·kg-1 esketamine was administered by vein in one minute, and 0.25mg·kg-1 esketamine was given at the beginning of the surgery.', 'interventionNames': ['Drug: Esketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group S', 'description': '1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 4% sevoflurane(FIO2=100%, 3L·min-1) was used to induce anesthesia by mask inhalation and 2-4 % sevoflurane (adjusted according to the depth of the anaesthesia,FIO2=100%, 2L·min-1) was maintained.', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Esketamine', 'type': 'DRUG', 'otherNames': ['s(+)ketamine'], 'description': '0.25 mg/kg esketamine for induction and 0.25 mg/kg esketamine at the beginning of surgery', 'armGroupLabels': ['Group E']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevoflurane Inhalation Solution'], 'description': '4% sevoflurane for induction and 2-4% sevoflurane for maintain', 'armGroupLabels': ['Group S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Fang Tan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eye & ENT Hospital of Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}