Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-28 @ 6:03 AM
Study NCT ID:
NCT03760692
Status:
UNKNOWN
Last Update Posted:
2022-03-28
First Post:
2018-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, multicenter, randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2018-11-29', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insertion time', 'timeFrame': 'intraoperative', 'description': 'The time taken to successfully place the device in seconds'}, {'measure': 'Change in airway seal pressure', 'timeFrame': 'intraoperative', 'description': 'The maximum oropharyngeal leak pressure attained for each device.'}], 'secondaryOutcomes': [{'measure': 'Number of attempts at insertion', 'timeFrame': 'intraoperative', 'description': 'The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['supraglottic airway device', 'laparoscopic gynecological surgery'], 'conditions': ['Airway Morbidity', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'To compare the effects of i-gel and Ambu AuraGain on ventilation parameters and surgical view during Trendelenburg position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents.', 'detailedDescription': "Prospective, multicenter, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.\n\nThe patients are randomly assigned to 2 groups:\n\nGroup i-gel Group Ambu AuraGain\n\nProcedure:\n\nThe investigation protocol contains the following sections:\n\n1. Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion, IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway device.\n2. Bispectral index values will be held between 40-60.Bispectral index values will be within this interval by increasing or decreasing propofol infusion by 1 mg/kg after additional bolus dose of propofol (1 mg/kg).\n3. Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations.\n4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 4-10 mg/kg/hr propofol IV infusion\n5. Functionality of the gastric drainage channel of the airway device\n6. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2), before desufflation (T3), before removal of airway device (T4). The maximum pressure allowed is 40 cm H2O.\n7. Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and at T1, T2, T3 and T4.\n8. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway intervention requirements, hypoxia (SpO2 \\< 92%)\n9. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace amounts of blood; 3: clear amounts of blood). Complications: sore throat ( VAS:10-point scale), dysphonia (yes/no), dysphagia (yes/no)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA classification I-II\n* Between 18-65 years\n* Undergoing elective laparoscopic gynecological surgery\n\nExclusion Criteria:\n\n1. Those with any neck or upper respiratory tract pathology\n2. Those at risk of gastric content regurgitation/aspiration (previous upper GIS surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy)\n3. Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)\n4. Obese patients (BMI \\>35)\n5. Those with throat pain, dysphagia and dysphonia\n6. Those with possible or previous difficult airway\n7. Those with operations planned for longer than 4 hours\n8. Conversion to laparotomy\n9. Neuromuscular blocking agent used'}, 'identificationModule': {'nctId': 'NCT03760692', 'briefTitle': 'I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Comparison of I-gel and Ambu AuraGain Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery', 'orgStudyIdInfo': {'id': '351-SBKAEK'}, 'secondaryIdInfos': [{'id': 'HUSE 012-ANR-2017', 'type': 'OTHER', 'domain': 'Hospital Universitario del Sureste'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group i-gel', 'description': "Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance", 'interventionNames': ['Device: i-gel']}, {'type': 'EXPERIMENTAL', 'label': 'Group Ambu Auragain', 'description': "Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance", 'interventionNames': ['Device: Ambu AuroGain']}], 'interventions': [{'name': 'i-gel', 'type': 'DEVICE', 'otherNames': ['Group i-gel'], 'description': 'Evaluation of clinical performance in terms of insertion, ventilation and complications', 'armGroupLabels': ['Group i-gel']}, {'name': 'Ambu AuroGain', 'type': 'DEVICE', 'otherNames': ['Group Ambu AuroGain'], 'description': 'Evaluation of clinical performance in terms of insertion, ventilation and complications', 'armGroupLabels': ['Group Ambu Auragain']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Sureste University Hospital, Department of Anesthesiology and Critical Care', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Sule Ozbilgin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Sule Ozbilgin', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}