Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT02888067
Status:
TERMINATED
Last Update Posted:
2023-10-23
First Post:
2016-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2016-08-12', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Five-point surgical rating scale (SRS)', 'timeFrame': 'during surgery, an average period of 50 minutes', 'description': 'Surgical conditions during surgery will be assessed by the surgeon using a five-point surgical rating scale at 10 minutes intervals'}], 'secondaryOutcomes': [{'measure': 'Drug dosages', 'timeFrame': 'Through study completion, an average of 4 hours', 'description': 'Drugs and dosages used during the study'}, {'measure': 'Time to extubation', 'timeFrame': 'During the stay in the operation room, an average of 60 minutes', 'description': 'Time from reversal to optimal extubation conditions (TOF ratio \\<0.9)'}, {'measure': 'Heart rate', 'timeFrame': 'During the stay in the operation and recovery room, an average of 4 hours'}, {'measure': 'Arterial blood pressure', 'timeFrame': 'During the stay in the operation and recovery room, an average of 4 hours'}, {'measure': 'Oxygen saturation', 'timeFrame': 'During the stay in the operation and recovery room, an average of 4 hours'}, {'measure': 'Respiratory rate', 'timeFrame': 'During the stay in the operation and recovery room, an average of 4 hours'}, {'measure': 'Body temperature', 'timeFrame': 'During the stay in the operation and recovery room, an average of 4 hours'}, {'measure': 'Duration of surgery', 'timeFrame': 'During the stay in the operation room, an average of 50 minutes'}, {'measure': 'Duration of post-anesthesia care unit (PACU) stay', 'timeFrame': 'During the stay in the recovery room, an average of 3 hours', 'description': 'Time spent in the PACU'}, {'measure': 'Pain score', 'timeFrame': 'During the stay in the operation and recovery room, an average of 4 hours', 'description': 'On an 11-point numerical rating scale from 0 = no pain, to 10 = most severe pain imaginable at PACU'}, {'measure': 'Occurence of nausea/vomiting', 'timeFrame': 'During the stay in the operation and recovery room, an average of 4 hours'}, {'measure': 'Sedation', 'timeFrame': 'During the stay in the operation and recovery room, an average of 4 hours', 'description': 'On a five-point scale ranging from 0 = normal alertness to 5 = not aroused by a painful stimulus at PACU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromuscular Blockade'], 'conditions': ['High-Frequency Jet Ventilation', 'Vocal Cord Resection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether deep neuromuscular blockade provides better surgical conditions than moderate neuromuscular blockade in patients undergoing vocal cord resections requiring jet ventilation.', 'detailedDescription': 'To optimize anatomical exposure and to minimize direct manipulation of local lesions endotracheal intubation often is avoided in patients undergoing vocal cord surgery.\n\nInstead intermittent so called jet ventilation is carried out by using the Hunsaker Mon-jet tube. The safe conduct of these procedures requires full muscle paralysis. In clinical practice, however, deep neuromuscular blockade (NMB) usually cannot be established for this relatively short surgery (\\<1h) because of an increased risk of prolonged NMB and postoperative ventilation.\n\nThe novel neuromuscular blockade reversal agent sugammadex may prove particularly useful in this patient population because it allows fast and reliable reversal of even deep NMB. Deeper muscle paralysis during vocal cord surgery may be associated with better surgical conditions.\n\nThe purpose of this study is to determine whether deep neuromuscular blockade provides better surgical conditions than moderate neuromuscular blockade in patients undergoing vocal cord resections requiring jet ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective vocal cord resection with an expected length of the procedure longer than 20 minutes and requiring jet ventilation\n\nExclusion Criteria:\n\n* Patients younger than 18 years old\n* Patients unable to give written informed consent\n* Patients with known or suspected neuromuscular disease\n* Patients with allergies to medications to be used during anesthesia\n* Patients with a (family) history of malignant hyperthermia\n* Patients with renal insufficiency (serum creatinine \\>2 times normal or a glomerular filtration rate \\<60 ml/h)'}, 'identificationModule': {'nctId': 'NCT02888067', 'briefTitle': 'Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation in Patients With Moderate vs. Deep Neuromuscular Block', 'orgStudyIdInfo': {'id': '2017-2754'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate neuromuscular blockade (MNB)', 'description': 'The goal is to realize a moderate NMB (TOF 1-2 twitches). NMB will be induced with a bolus dose of rocuronium (Non-depolarizing Skeletal Neuromuscular Blocking Agent). If the target TOF values was not reached bolus doses of rocuronium (5 mg) will be given to achieve the target.\n\nThis represents the standard care in our institution for this type of surgery. At the end of surgery, neuromuscular blockade in all patients will be reversed by sugammadex: patients in the moderate neuromuscular blockade group will receive sugammadex (Selective Relaxant Binding Agent).', 'interventionNames': ['Drug: Rocuronium bromide 0.5 mg/kg', 'Drug: Sugammadex sodium 2 mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Deep neuromuscular blockade (MNB)', 'description': 'The goal is to realize a deep MNB (TOF zero twitches). NMB will be induced with a bolus dose of rocuronium (Non-depolarizing Skeletal Neuromuscular Blocking Agent). If the target TOF values was not reached bolus doses of rocuronium (5 mg) will be given to achieve the target.\n\nAt the end of surgery, neuromuscular blockade in all patients will be reversed by sugammadex: patients in the deep neuromuscular blockade group will receive sugammadex (Selective Relaxant Binding Agent).', 'interventionNames': ['Drug: Rocuronium bromide 1.0 mg/kg', 'Drug: Sugammadex sodium 4 mg/kg']}], 'interventions': [{'name': 'Rocuronium bromide 0.5 mg/kg', 'type': 'DRUG', 'otherNames': ['Zemuron®'], 'description': 'Moderate neuromuscular blockade with rocuronium bromide', 'armGroupLabels': ['Moderate neuromuscular blockade (MNB)']}, {'name': 'Rocuronium bromide 1.0 mg/kg', 'type': 'DRUG', 'otherNames': ['Zemuron®'], 'description': 'Deep neuromuscular blockade with rocuronium bromide', 'armGroupLabels': ['Deep neuromuscular blockade (MNB)']}, {'name': 'Sugammadex sodium 2 mg/kg', 'type': 'DRUG', 'otherNames': ['Bridion™'], 'description': 'Reversal with sugammadex sodium', 'armGroupLabels': ['Moderate neuromuscular blockade (MNB)']}, {'name': 'Sugammadex sodium 4 mg/kg', 'type': 'DRUG', 'otherNames': ['Bridion™'], 'description': 'Reversal with sugammadex sodium', 'armGroupLabels': ['Deep neuromuscular blockade (MNB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4A3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'MUHC', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Thomas Schricker, M.D., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Schricker', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman,Department of Anesthesia', 'investigatorFullName': 'Thomas Schricker', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}