Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-28 @ 5:05 PM
Study NCT ID:
NCT01687894
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2012-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasopressin to Prevent Hypotension During Beach Chair Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}], 'ancestors': [{'id': 'D002805', 'term': 'Chondrocalcinosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D018686', 'term': 'Anesthetics, Intravenous'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D018681', 'term': 'Anesthetics, General'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'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'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2012-09-08', 'studyFirstSubmitQcDate': '2012-09-15', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cerebral oxygen desaturation', 'timeFrame': 'Up to 30 min after the position change', 'description': 'Continuously observe near-infrared spectroscopy measured cerebral oxygenation before and after beach chair position whether oxygen saturation decrease more than 20% from pre-sitting values'}], 'primaryOutcomes': [{'measure': 'The magnitude of decrease of mean arterial pressure', 'timeFrame': 'Baseline (before positioning) and lowest value within 10 min into beach chair position', 'description': 'Continuously measure mean arterial blood pressure before and after position change. Calculate the magnitude of maximum decrease of mean arterial pressure from baseline'}], 'secondaryOutcomes': [{'measure': 'Jugular venous oxygen desaturation', 'timeFrame': 'Up to 30 min after the positioning', 'description': 'Jugular venous oxygen saturation is continuously measured whether its saturation is decreased below 50% or/and 40% for longer than 5 min.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral oxygen saturation', 'beach chair position', 'hemodynamic', 'jugular venous oximetry'], 'conditions': ['Rotator Cuff Tear Arthropathy']}, 'referencesModule': {'references': [{'pmid': '28558702', 'type': 'DERIVED', 'citation': 'Jang EA, Song JA, Shin JY, Yoon JJ, Yoo KY, Jeong S. Background anaesthetic agents do not influence the impact of arginine vasopressin on haemodynamic states and cerebral oxygenation during shoulder surgery in the beach chair position: a prospective, single-blind study. BMC Anesthesiol. 2017 May 30;17(1):73. doi: 10.1186/s12871-017-0364-9.'}]}, 'descriptionModule': {'briefSummary': 'Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia. The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are evaluated during surgery in BCP.', 'detailedDescription': 'Patients undergoing shoulder surgery in BCP under general anaesthesia are randomly allocated to receive i.v. normal saline (control group) or AVP 0.05 or 0.07 U kg-1 (AVP group, n = 15 each) 2 min before moving into BCP. Mean arterial pressure (MAP), heart rate (HR), jugular venous bulb oxygen saturation (SjvO2) and regional cerebral tissue oxygen saturation (SctO2) are measured before (pre-sitting in supine position) and after patients assumed BCP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing shoulder surgery in the beach chair position under the general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: elective arthroscopic shoulder surgery under general anesthesia in beach chair position\n\nExclusion Criteria: preexisting cerebrovascular diseases, history of orthostatic hypotension, age less than 18 yr, and the American Society of Anesthesiologists physical status IV or V'}, 'identificationModule': {'nctId': 'NCT01687894', 'briefTitle': 'Vasopressin to Prevent Hypotension During Beach Chair Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'Clinical Trials of Vasopressin for Prevention of Hypotension During Shoulder Surgery in Beach Chair Position Under General Anesthesia', 'orgStudyIdInfo': {'id': 'CNUH-2012-074'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vasopressins & propofol', 'description': 'Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.', 'interventionNames': ['Drug: Vasopressins', 'Drug: propofol']}, {'label': 'Placebo & propofol', 'description': 'Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia', 'interventionNames': ['Drug: Placebo', 'Drug: propofol']}, {'label': 'Vasopressins & sevoflurane', 'description': 'Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia', 'interventionNames': ['Drug: Vasopressins', 'Drug: sevoflurane']}, {'label': 'Placebo & sevoflurane', 'description': 'Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia', 'interventionNames': ['Drug: Placebo', 'Drug: sevoflurane']}], 'interventions': [{'name': 'Vasopressins', 'type': 'DRUG', 'otherNames': ['Arginine vasopressin'], 'description': 'Vasopressins propofol vasopressins sevoflurane', 'armGroupLabels': ['Vasopressins & propofol', 'Vasopressins & sevoflurane']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['saline 10 ml as placebo'], 'description': 'Placebo propofol \\& placebo sevoflurane', 'armGroupLabels': ['Placebo & propofol', 'Placebo & sevoflurane']}, {'name': 'propofol', 'type': 'DRUG', 'otherNames': ['Intravenous anesthetic'], 'description': 'vasopressin propofol \\& placebo propofol', 'armGroupLabels': ['Placebo & propofol', 'Vasopressins & propofol']}, {'name': 'sevoflurane', 'type': 'DRUG', 'otherNames': ['general anesthetic'], 'description': 'vasopressins sevoflurane placebo sevoflurane', 'armGroupLabels': ['Placebo & sevoflurane', 'Vasopressins & sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}], 'overallOfficials': [{'name': 'Kyung Y Yoo, M.D.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chonnam National University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kyung Yeon Yoo', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}}