Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-04 @ 4:37 PM
Study NCT ID:
NCT05313100
Status:
COMPLETED
Last Update Posted:
2022-04-18
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sugammadex and Smoker's Neuromuscular Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuromuscular block recovery time', 'timeFrame': 'six months', 'description': 'Time to reach TOF %90 measurement after given neuromuscular blocker reverse agent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sugammadex', 'smoking', 'neuromuscular blockade'], 'conditions': ['Neuromuscular Blockade', 'Smoking']}, 'descriptionModule': {'briefSummary': 'We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization.', 'detailedDescription': '40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at least 10 years or non-smokers, who will undergo elective surgery were included in this randomized prospective study. Patients underwent routine monitoring and neuromuscular monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction. After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 + 50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four) counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgery,\n* 1-2 according to the ASA ( American Society of Anesthesiologist ) physical status classification.\n* Patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking\n* Or never smoked patients\n\nExclusion Criteria:\n\n* neuromuscular diseases\n* radiotherapy and/or chemotherapy anamnesis,\n* liver and/or renal disease,\n* electrolyte balance,\n* history of drug use which affects neuromuscular transmission,\n* Body Mass Index (BMI) of more than 27,\n* use alcohol'}, 'identificationModule': {'nctId': 'NCT05313100', 'briefTitle': "Sugammadex and Smoker's Neuromuscular Block", 'organization': {'class': 'OTHER', 'fullName': 'Duzce University'}, 'officialTitle': 'The Evaluation of the Effects of the Use of Rocuronium and Sugammadex on Neuromuscular Block in Smoker', 'orgStudyIdInfo': {'id': '2012.04.HD.067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Smokers', 'description': 'The patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking were included in the smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used.', 'interventionNames': ['Drug: sugammadex']}, {'type': 'SHAM_COMPARATOR', 'label': 'Nonsmokers', 'description': 'The patients who never smoked were included in the non-smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used.', 'interventionNames': ['Drug: sugammadex']}], 'interventions': [{'name': 'sugammadex', 'type': 'DRUG', 'otherNames': ['bridion'], 'description': 'At the end of the operation, at least 15 minutes after the last dose of rocuronium, sugammadex 2 mg / kg was administered both of groups', 'armGroupLabels': ['Nonsmokers', 'Smokers']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gulbin Sezen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Duzce University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duzce University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}