Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-27 @ 3:34 PM
Study NCT ID:
NCT04664595
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2014-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '4 second generation of supraglottic airway device'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2020-12-06', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability of propofol for supragloqtic airway devices insertion', 'timeFrame': '2 years', 'description': 'The effect-site concentration of propofol required to insert supraglottic airway devices.'}], 'secondaryOutcomes': [{'measure': 'Blood pressure changes from baseline after insertion of supraglottic devices', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Target Controlled Infusion', 'Supraglottic airway device', 'Propofol', 'Supreme™', 'ProSeal™', 'I-gel™', 'Laryngeal Tube Suction II™'], 'conditions': ['Appropriate Affect', 'Complication of Device Insertion']}, 'descriptionModule': {'briefSummary': 'to evaluate and compare the effect-site concentration of propofol with the TCI system for second-generation SGA device insertion between the I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™.\n\nto determine the hemodynamic changes during insertion of supraglottic devices in patients undergoing elective surgery and any complications after device insertion.', 'detailedDescription': 'The investigators enrolled ASA physical status I-III patients who were 18-70 years old and scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.), reactive airway disease, signs of respiratory infection or a plan to remain intubated were excluded from the study. The investigators also excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index \\> 35 kg/m2).\n\nPatients were randomized into 4 groups (I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™ SGAs) according to a computer generated randomization list and patients were allocated consecutively. The sample size of each group required 10 patients.\n\nAll patients were pre-oxygenated with 100% oxygen. After the administration of 2 µg/ml intravenous fentanyl for 5 minutes, anesthesia was induced with the Schnider pharmacokinetic TCI system. After equilibration of the plasma-site and effect-site concentrations in propofol TCI, 1 of the 4 types of SGA was randomly inserted by two anesthesiologists (resident trainee and staff doctor) who were unaware of the actual plasma concentration of propofol without the use of a muscle relaxant.\n\nThe response of each patient determined the effect-site concentration of propofol of the next patient. "No Response" was defined as Laryngeal Mask Airway Insertion Score = 0 and "Response" was defined as Laryngeal Mask Airway Insertion Score ≥ 1. If the insertion of the supraglottic airway device was successful ("No Response"), then the target effect-site concentration was decreased by a step of 0.4 µg/ml. If the insertion failed ("Response"), the target effect-site concentration was increased by the same dose. The patients\' responses to LMA insertion was classified by blinded investigators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I-III patients.\n* Patients 18-70 years old .\n* Patients scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.\n\nExclusion Criteria:\n\n* Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.).\n* Adults with reactive airway disease.\n* Adults with signs of respiratory infection or a plan to remain intubated were excluded from the study.\n* Excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index \\> 35 kg/m2).'}, 'identificationModule': {'nctId': 'NCT04664595', 'briefTitle': 'Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices', 'orgStudyIdInfo': {'id': '55-213-08-1-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Group SP', 'description': 'The Supreme™ group', 'interventionNames': ['Drug: Propofol Fresenius']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group PS', 'description': 'The ProSeal™ group', 'interventionNames': ['Drug: Propofol Fresenius']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group IG', 'description': 'The I-gel™ group', 'interventionNames': ['Drug: Propofol Fresenius']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group LT', 'description': 'The Laryngeal Tube Suction IITM group', 'interventionNames': ['Drug: Propofol Fresenius']}], 'interventions': [{'name': 'Propofol Fresenius', 'type': 'DRUG', 'description': 'final dose of Propofol (mcg/kg) to reach the target effect-site concentration', 'armGroupLabels': ['Group IG', 'Group LT', 'Group PS', 'Group SP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Price of Songkla University', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}, {'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Songklanagarind Hospital', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nalinee Kovitwanawong', 'investigatorAffiliation': 'Prince of Songkla University'}}}}