Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
Study NCT ID:
NCT06676969
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High vs. Low Flow Sevoflurane Anesthesia in Pediatric Laparoscopic Surgery: Recovery, Hemodynamics, and Cost Comparison
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery times with Aldrete recovery score', 'timeFrame': '15/09/24-30/11/24'}], 'secondaryOutcomes': [{'measure': 'Incidence of intraoperative hypothermia by esophageal temperature measurements', 'timeFrame': '15/09/24-30/11/24'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic surger', 'Low-flow anesthesia', 'Pediatric Patient'], 'conditions': ['Low-flow Anesthesia']}, 'referencesModule': {'references': [{'pmid': '16390568', 'type': 'BACKGROUND', 'citation': 'Isik Y, Goksu S, Kocoglu H, Oner U. Low flow desflurane and sevoflurane anaesthesia in children. Eur J Anaesthesiol. 2006 Jan;23(1):60-4. doi: 10.1017/S026502150500178X.'}, {'pmid': '23277809', 'type': 'BACKGROUND', 'citation': 'Park SY, Chung CJ, Jang JH, Bae JY, Choi SR. The safety and efficacy of minimal-flow desflurane anesthesia during prolonged laparoscopic surgery. Korean J Anesthesiol. 2012 Dec;63(6):498-503. doi: 10.4097/kjae.2012.63.6.498. Epub 2012 Dec 14.'}, {'pmid': '32786105', 'type': 'BACKGROUND', 'citation': 'Glenski TA, Levine L. The implementation of low-flow anesthesia at a tertiary pediatric center: A quality improvement initiative. Paediatr Anaesth. 2020 Oct;30(10):1139-1145. doi: 10.1111/pan.13994. Epub 2020 Aug 29.'}, {'pmid': '10616333', 'type': 'BACKGROUND', 'citation': 'Meakin GH. Low-flow anaesthesia in infants and children. Br J Anaesth. 1999 Jul;83(1):50-7. doi: 10.1093/bja/83.1.50. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of our study is to compare the effects of different flow rates of the routinely used inhalation agent, sevoflurane, on postoperative recovery times in pediatric patients undergoing elective laparoscopic surgeries. Our secondary objectives are to evaluate the impact of different flow rates on hemodynamic parameters, ventilation parameters, and costs.', 'detailedDescription': "Low-flow anesthesia is a technique in which at least 50% of the exhaled gas is returned to the system through rebreathing. When using modern rebreathing systems, low-flow anesthesia can be defined if the fresh gas flow rate is reduced below 2 L/min. This anesthesia method involves using an anesthesia system with rebreathing capabilities, where carbon dioxide is removed from the gas mixture exhaled by the patient, and then at least 50% of the fresh oxygen flow, along with volatile anesthetics sufficient to meet the body's metabolic requirements, is returned to the patient.\n\nThe application of low-flow anesthesia reduces the consumption of anesthetic gases, decreases the cost of anesthesia, minimizes contamination of the working environment and atmosphere with anesthetic gases, preserves the respiratory physiology of the patient, and minimizes heat and humidity loss by heating and humidifying the gases delivered to the patient, thereby better maintaining the physiology of the trachea and bronchial environments. The heating of gases is also beneficial for maintaining body temperature and preventing postoperative hypothermia. Additionally, due to the requirement for close monitoring, anesthesia safety is increased .\n\nIn pediatric patients, due to their different anatomical and physiological characteristics compared to adults, the application of low fresh gas flow anesthesia can be more challenging. This is especially the case when using uncuffed endotracheal tubes, where leaks may occur in the respiratory system, and the breathing circuits used may increase dead space. However, studies have shown that with appropriate techniques and adequate monitoring, these potential problems can be prevented, and low-flow anesthesia can be safely applied in children with close monitoring.\n\nIn our study, the investigators aim to compare the effects of different flow rates on postoperative recovery, hemodynamic factors, and costs in children, and to demonstrate that low-flow anesthesia can be applied as safely as high-flow anesthesia in pediatric patients. The investigators believe our study will contribute significantly to the literature on this topic."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients undergoing laparoscopic surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatients with an American Society of Anesthesiologists (ASA) classification of I-II.\n\nElective laparoscopic surgeries expected to last longer than 30 minutes but shorter than 180 minutes\n\nExclusion Criteria:\n\nPatients who are not candidates for laparoscopic surgery. Patients unsuitable for low-flow anesthesia due to inadequate monitoring conditions.\n\nPatients whose relatives are unable to provide informed consent. Patients with an American Society of Anesthesiologists (ASA) classification higher than II.'}, 'identificationModule': {'nctId': 'NCT06676969', 'briefTitle': 'High vs. Low Flow Sevoflurane Anesthesia in Pediatric Laparoscopic Surgery: Recovery, Hemodynamics, and Cost Comparison', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Evaluation of High and Low Flow Sevoflurane Anesthesia in Pediatric Patients Undergoing Laparoscopic Surgeries in Terms of Recovery, Hemodynamics, and Cost', 'orgStudyIdInfo': {'id': 'High/Low flow Anestesia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low flow', 'description': 'Low flow Anestesia'}, {'label': 'High Flow', 'description': 'High Flow Anestesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55200', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': '19 Mayis Üniversitesi Tip Fakültesi', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': '55200', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': '19 Mayıs Üniversitesi Tıp Fakültesi', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sibel Barış', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}