Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT06215833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recovery of TIVA vs Inhalation in Pediatric Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-27', 'studyFirstSubmitDate': '2023-12-10', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of consciousness score', 'timeFrame': 'About 20 minutes after stopping anesthesia and emergence from anesthesia begin', 'description': '* Awake =2\n* Arousal with minimal stimulation =1\n* Responsive only to tactile stimulation =0\n* No score 0 is required \\& High score mean more safe and better method of anesthesia .'}, {'measure': 'physical activity score', 'timeFrame': 'About 20 minutes after stopping anesthesia and emergence from anesthesia begin', 'description': '* Able to move on command =2\n* Some weakness in movement = 1\n* Unable to voluntarily move = 0\n* No score 0 is required \\& High score mean more safe and better method of anesthesia .'}, {'measure': 'hemodynamic stability score', 'timeFrame': 'About 20 minutes after stopping anesthesia and emergence from anesthesia begin', 'description': '* Blood pressure \\< 15% of baseline MAP value =2\n* Blood pressure 15%-30% of baseline MAP value =1\n* Blood pressure \\< 30% below baseline MAP value =0\n* No score 0 is required \\& High score mean more safe and better method of anesthesia .'}, {'measure': 'respiratory stability score', 'timeFrame': 'About 20 minutes after stopping anesthesia and emergence from anesthesia begin', 'description': '* Able to breathe deeply = 2\n* Tachypnea with good coughs =1\n* Dyspneic with weak cough = 0\n* No score 0 is required \\& High score mean more safe and better method of anesthesia .'}, {'measure': 'Oxygen saturation score', 'timeFrame': 'About 20 minutes after stopping anesthesia and emergence from anesthesia begin', 'description': '* Maintain value \\> 90% on room air = 2\n* Requires supplemental O2 to maintain value \\> 90% = 1\n* So2 \\< 90% with supplemental O2 = 0\n* No score 0 is required \\& High score mean more safe and better method of anesthesia .'}, {'measure': 'post operative pain score', 'timeFrame': 'About 20 minutes after stopping anesthesia and emergence from anesthesia begin', 'description': '* None or mild = 2\n* Moderate to severe pain controlled =1\n* Persistent severe pain = 0\n* No score 0 is required \\& High score mean more safe and better method of anesthesia .'}, {'measure': 'post operative emetic score', 'timeFrame': 'About 20 minutes after stopping anesthesia and emergence from anesthesia begin', 'description': '* None or mild nausea with no active vomiting = 2\n* Transient vomiting =1\n* Persistent moderate to severe nausea and vomiting=0\n* No score 0 is required \\& High score mean more safe and better method of anesthesia .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Best Technique for Pediatric Anesthesia']}, 'descriptionModule': {'briefSummary': 'Compare recovery profile from TIVA and that of total inhalational anesthesia in ambulatory pediatric tonsillectomy and which strategy is more safe and less cost and more smooth in pediatric anesthesia.', 'detailedDescription': 'Complications in pediatric anesthesia can happen even in our modern hospitals with the most advanced equipment and skilled anesthesiologists.\n\nTypical complications in pediatric anesthesia are respiratory problems , medication errors , difficulties with intravenous puncture , and pulmonal aspiration. In postoperative setting , nausea and vomiting , pain , emergence delirium can be mentioned as typical complications.\n\nThe choice of anesthetic agent and techniques can influence the occurrence of these complications and thus delay in discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children planned for ambulatory tonsillectomy from primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child between 4 to 10 years\n* without co morbidity\n* ASA score 1\n* mallampati score 1 and 2\n\nExclusion Criteria:\n\n* child below 4 years and above 10 years\n* child with co morbidity\n* ASA score above 1\n* mallampati score 3 and 4'}, 'identificationModule': {'nctId': 'NCT06215833', 'briefTitle': 'Recovery of TIVA vs Inhalation in Pediatric Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison of Emergence and Recovery Profile After Total Intravenous Anesthesia ( TIVA ) Vs Inhalational Anesthesia in Opioid Free Pediatric Tonsillectomy', 'orgStudyIdInfo': {'id': 'TIVA vs inhalation anesthesia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group ( p )', 'description': 'This group will undergo anesthesia via total intravenous anesthesia using Propofol in induction and maintenance', 'interventionNames': ['Drug: Propofol']}, {'label': 'Group ( s )', 'description': 'This group undergo anesthesia via total inhalational anesthesia using sevoflurane in induction and maintenance', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Cetal suppository'], 'description': 'All children will undergo anesthesia via Propofol bolus injection in induction then Propofol infusion in maintenance of anesthesia and will be given after total recovery, Cetal suppositories as postoperative analgesia', 'armGroupLabels': ['Group ( p )']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Cetal suppository'], 'description': 'All children will undergo anesthesia via Sevoflurane will be given during induction then through maintenance of anesthesia and will be given after total recovery, Cetal suppositories as post operative analgesia', 'armGroupLabels': ['Group ( s )']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Mahmoud Sayed', 'investigatorAffiliation': 'Assiut University'}}}}