Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2026-01-24 @ 5:33 AM
Study NCT ID:
NCT02974712
Status:
UNKNOWN
Last Update Posted:
2016-11-28
First Post:
2016-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Two Induction Means on Emergence After General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-25', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-25', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean arterial pressure (MAP)', 'timeFrame': 'One hour after surgery'}], 'secondaryOutcomes': [{'measure': 'Lengths of stays in the Post anesthesia care unit(PACU)', 'timeFrame': 'One hour after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arterial blood gases', 'MAP', 'HR'], 'conditions': ['Mean Arterial Pressure', 'Heart Rate']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of different methods of administration on emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral endoscopic operation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA level I or II,\n* Aged from 65 to 79,\n* With a duration of anesthesia \\<90 min.\n\nExclusion Criteria:\n\n* Chronic obstructive pulmonary diseases (COPD),\n* Severe heart disease,\n* Difficult airway\n* Liver and kidney dysfunction,\n* Cerebrovascular disease,\n* Bleeding volume \\>20 ml.'}, 'identificationModule': {'nctId': 'NCT02974712', 'briefTitle': 'The Effects of Two Induction Means on Emergence After General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'The Effects of Two Induction Means on Emergence After General Anesthesia for Elderly Patients Undergoing Transurethral Endoscopic Operation', 'orgStudyIdInfo': {'id': '20161114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl', 'description': 'After routine Induction, fentanyl was administrated.', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'After routine Induction, same volume saline was administrated.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'armGroupLabels': ['Fentanyl']}, {'name': 'Saline', 'type': 'DRUG', 'armGroupLabels': ['Saline']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}