Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-05-12 @ 8:36 PM
Study NCT ID:
NCT01171833
Status:
COMPLETED
Last Update Posted:
2012-08-13
First Post:
2010-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D000077335', 'term': 'Desflurane'}, {'id': 'D007530', 'term': 'Isoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-09', 'studyFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2010-07-28', 'lastUpdatePostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End-tidal concentrations of isoflurane, sevoflurane and desflurane, and BIS values with hypo-, normo-, hyperventilation', 'timeFrame': 'at 0, 30, 60, 90, 120, 180, 240, 300, 360, 480, 600, 720 sec after volatile gas starts', 'description': 'The inspiratory, and end-tidal concentrations of volatile anesthetics, partial pressure of end-tidal carbon dioxide will be recorded from an S/5 Avance anesthetic workstation (Datex-Ohmeda) and an embedded monitor. BIS values are measured with a BIS monitor.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anesthetic induction', 'Desflurane', 'Isoflurane', 'Sevoflurane', 'Ventilation'], 'conditions': ['Pharmacokinetics of Inhaled Anesthetics']}, 'descriptionModule': {'briefSummary': 'Three groups of patients are going to have minor surgery under general anesthesia with inhaled anesthetics and different ventilatory setting (Tidal volume: 8, 10, 12 ml/kg, respiratory rate: 10/min each). Group A (Sevoflurane) will use sevoflurane, group B (Desflurane) will use desflurane, and group C (Isoflurane) will use isoflurane. It will be observed differences among the groups for ventilatory effects on speed of induction.\n\nDuration of this randomised controlled trial will be about 3 months. Estimated sample size will be 36 patients(12 in each group).', 'detailedDescription': 'No premedicant will be given. The anesthetic workstation and a circulatory circuit will be prefilled with 1.0 MAC of inhaled anesthetic that will be selected randomly.\n\n* Group A (n=12): Sevoflurane 2.0 vol%\n* Group B (n=12): Desflurane 6.0 vol%\n* Group C (n=12): Isoflurane 1.2 vol%\n\nEach group has 3 subgroups according to the ventilatory setting that will also be randomly determined.\n\n* Hypoventilation: tidal volume 8 ml/kg, respiratory rate 10 /min\n* Normoventilation: tidal volume 10 ml/kg, respiratory rate 10 /min\n* Hyperventilation: tidal volume 12 ml/kg, respiratory rate 10 /min\n\nPatients will be preoxygenated with 100% oxygen (5 L/min) for 5 minutes under pulse oximeter, EKG, and noninvasive blood pressure monitoring. Bispectral index (BIS) monitor will be applied.\n\nThe induction of general anesthesia will start with propofol (2 mg/kg), rocuronium (0.8 mg/kg) and remifentanil infusion (0.1 mcg/kg/min). The size of a tracheal tube will be 7.5 mm (ID) for male, 7.0 mm (ID) for female. After intubation, anesthesia workstation will be connected to the tracheal tube. Ventilation will start, and that point will be time 0. During 720 seconds, inspiratory (PIgas) and end-tidal concentration of inhaled anesthetics (ETgas), end-tidal partial pressure of carbon dioxide, and BIS will be measured at time 0, 30, 60, 90, 120 ,150, 180, 240, 300, 360, 480, 600, and 720 seconds. Mean blood pressure and heart rate will also be recorded every 2 minutes. Fresh gas flow will be kept at 6 L/min with 100% oxygen.\n\nThe fraction of ETgas/PIgas will be analyzed with nonlinear mixed effects modeling.\n\nEstimated sample size will be 36 patients (12 in each group, 4 in each ventilatory settings).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA PS I, II\n* Age: 20-60 years male and female\n* Elective schedule with minor surgery\n* BMI \\< 30\n\nExclusion Criteria:\n\n* Patients with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history\n* Upper airway anomaly or deformity\n* ASA PS III or higher\n* Pregnant women\n* BMI \\>= 30'}, 'identificationModule': {'nctId': 'NCT01171833', 'briefTitle': 'Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics', 'organization': {'class': 'OTHER', 'fullName': 'DongGuk University'}, 'officialTitle': 'Effect of Ventilation on Speed of Induction of Anesthesia in Desflurane, Sevoflurane, and Isoflurane', 'orgStudyIdInfo': {'id': 'J In 2010-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A(Sevoflurane)', 'description': 'Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings.\n\nEach subgroup has 4 patients.\n\nA8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Group B(Desflurane)', 'description': 'Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings.\n\nEach subgroup has 4 patients.\n\nA8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)', 'interventionNames': ['Drug: Desflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Group C(Isoflurane)', 'description': 'Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings.\n\nEach subgroup has 4 patients.\n\nA8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)', 'interventionNames': ['Drug: Isoflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevorane'], 'description': '2.0 vol% prefilled in a corrugated circuit.', 'armGroupLabels': ['Group A(Sevoflurane)']}, {'name': 'Desflurane', 'type': 'DRUG', 'otherNames': ['Suprane'], 'description': '6.0 vol% prefilled in a corrugated circuit.', 'armGroupLabels': ['Group B(Desflurane)']}, {'name': 'Isoflurane', 'type': 'DRUG', 'otherNames': ['Aerane'], 'description': '1.2 vol% prefilled in a corrugated circuit.', 'armGroupLabels': ['Group C(Isoflurane)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Junyong In, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DongGuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Junyong In', 'investigatorAffiliation': 'DongGuk University'}}}}