Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-22 @ 9:43 AM
Study NCT ID:
NCT02510157
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2015-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexamethasone on the Action of Sugammadex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-02', 'studyFirstSubmitDate': '2015-05-16', 'studyFirstSubmitQcDate': '2015-07-26', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time from end of surgery to extubation of patient', 'timeFrame': 'minutes after administration of sugammadex (0 to 30 minutes)', 'description': 'measurement of time after administration of the reversal agent (sugammadex) to achieve extubation of patient (up to 30 minutes)'}], 'primaryOutcomes': [{'measure': 'Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex', 'timeFrame': 'minutes after administration of sugammadex (0 to 30 minutes)', 'description': 'measurement of time after administration of the reversal agent (sugammadex) to achieve train-of-four (TOF0 ratio of 0.9 (up to 30 minutes)'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '1, 6, 12, 24 hours postoperatively', 'description': 'Assessed by Numeric Rating Scale 0-10'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': '1, 6, 12, 24 hours postoperatively', 'description': 'Assessed by nausea/vomiting scale (11. Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth 2012; 108: 423-429)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sugammadex', 'dexamethasone', 'neuromuscular blockade'], 'conditions': ['Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the possible clinical effect of dexamethasone on the action of sugammadex when it is administered to reverse deep neuromuscular blockade caused by rocuronium in laparoscopic cholecystectomies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18-70 years\n* laparoscopic cholecystectomy\n* operation \\< 3 hours\n\nExclusion Criteria:\n\n* age \\<18 or \\>70 years old\n* ASA physical status \\>3\n* central nervous system diseases\n* severe psychiatric disorders under treatment\n* cognitive dysfunction\n* known or suspected allergy to the administered drugs\n* operations \\> 3 hours\n* surgical intraoperative complications-open cholecystectomy\n* severe renal or liver disease\n* diabetes melitus\n* immunosuppressed patients\n* chronic immunosuppresant therapy (corticosteroids or other drugs)\n* all contraindications to corticosteroids administration\n* patiens on chronic use of opioids'}, 'identificationModule': {'nctId': 'NCT02510157', 'briefTitle': 'Effect of Dexamethasone on the Action of Sugammadex', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'orgStudyIdInfo': {'id': '711/19-3-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexamethasone', 'description': "Dexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.", 'interventionNames': ['Drug: Dexamethasone', 'Drug: sugammadex']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'description': "Normal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.", 'interventionNames': ['Drug: Normal Saline', 'Drug: sugammadex']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'active comparator', 'armGroupLabels': ['dexamethasone']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['N/S 0.9%'], 'description': 'placebo controlled intervention', 'armGroupLabels': ['normal saline']}, {'name': 'sugammadex', 'type': 'DRUG', 'description': 'sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery', 'armGroupLabels': ['dexamethasone', 'normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'country': 'Greece', 'facility': '2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens, Greece', 'investigatorFullName': 'Chrysanthi Batistaki', 'investigatorAffiliation': 'Attikon Hospital'}}}}