Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-24 @ 7:19 PM
Study NCT ID:
NCT01782820
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of a Single Dose Dexamethasone on the Time Course of Neuromuscular Blockade of Rocuronium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2013-01-31', 'studyFirstSubmitQcDate': '2013-02-01', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the time from start of injection of rocuronium until recovery to a train of four ratio (TOF ratio) of 0.9.', 'timeFrame': 'one hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neuromuscular Block, Dexamethasone', 'Neuromuscular Block, Recovery']}, 'referencesModule': {'references': [{'pmid': '24136379', 'type': 'DERIVED', 'citation': 'Soltesz S, Fraisl P, Noe KG, Hinkelbein J, Mellinghoff H, Mencke T. Dexamethasone decreases the duration of rocuronium-induced neuromuscular block: a randomised controlled study. Eur J Anaesthesiol. 2014 Aug;31(8):417-22. doi: 10.1097/EJA.0b013e328365c9ee.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to compare the time course of a neuromuscular block in patients receiving dexamethasone 8 mg in order to reduce postoperative nausea or vomiting several hours before surgery with patients receiving the drug immediately before induction of anaesthesia and patients without a dexamethasone prophylaxis. The primary end point is the time from start of injection of rocuronium until recovery to a train of four ratio (TOF ratio) of 0.9.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients of a primary care clinic undergoing elective gynecologic abdominal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18 to 65 years,\n* American Society of Anesthesiologists Physical Status I or II,\n* 50-90 kg body weight,\n* undergoing elective laparoscopic gynaecological surgery in general anaesthesia necessitating intraoperative neuromuscular blockade.\n\nExclusion Criteria:\n\n* expected difficulties with endotracheal intubation (history of difficult intubation,\n* reduced opening of the mouth (\\< 2cm), and Mallampati Score of 4),\n* increased risk of pulmonary aspiration (gastrooesophageal reflux, full stomach, intestinal obstruction),\n* known allergies to the drugs tested,\n* pregnancy,\n* neuromuscular disorders,\n* intake of drugs affecting neuromuscular blockade, such as furosemide, magnesium or cephalosporins,\n* hepatic-or renal insufficiency.'}, 'identificationModule': {'nctId': 'NCT01782820', 'briefTitle': 'Influence of a Single Dose Dexamethasone on the Time Course of Neuromuscular Blockade of Rocuronium', 'organization': {'class': 'OTHER', 'fullName': 'Kreiskrankenhaus Dormagen'}, 'orgStudyIdInfo': {'id': 'dexarelax'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'dexamethasone late', 'description': 'dexamethasone during induction of anesthesia'}, {'label': 'no dexamethasone', 'description': 'no dexamethasone during measurements'}, {'label': 'dexamethasone early', 'description': 'dexamethasone before induction of anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-51375', 'city': 'Dormagen', 'country': 'Germany', 'facility': 'Kreiskrankenhaus Dormagen', 'geoPoint': {'lat': 51.09683, 'lon': 6.83167}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kreiskrankenhaus Dormagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}