Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-01-01 @ 1:27 PM
Study NCT ID:
NCT00953550
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2009-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D013390', 'term': 'Succinylcholine'}], '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'}, {'id': 'D002794', 'term': 'Choline'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013386', 'term': 'Succinates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-01', 'studyFirstSubmitDate': '2009-08-05', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from verified correct tube placement after intubation to spontaneous respiration, defined as respiration frequency of >8/minute, tidal volume >3ml/kg and a saturation of >90% for 30 seconds.', 'timeFrame': '20 minutes'}], 'secondaryOutcomes': [{'measure': 'Duration of action. Measured as the time from administration of the neuromuscular blocking agent to the T1-value in Train-of-Four (TOF) returns to >90% of T1-max.', 'timeFrame': '20 minutes'}, {'measure': 'Intubation Difficulty Scale (IDS)', 'timeFrame': '20 minutes'}, {'measure': 'Intubation conditions', 'timeFrame': '20 minutes'}, {'measure': 'Side effect - Muscle ache.', 'timeFrame': 'Postoperative (within 24 hours)'}, {'measure': 'Side effect - Tachycardia (>100 beats per minute).', 'timeFrame': '20 minutes'}, {'measure': 'Side effect - Bradycardia (<50 beats per minute).', 'timeFrame': '20 minutes'}, {'measure': 'Side effect - Awareness/recall. Evaluated by modified Brice Questionaire.', 'timeFrame': 'Postoperative (within 24 hours)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rapid Sequence Intubation']}, 'descriptionModule': {'briefSummary': 'Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol.\n\nStudy hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgical patients with a planned rapid sequence induction of anaesthesia.\n* Informed consent.\n* Legally competent.\n* Be able to understand Danish and be able to read the given information in Danish.\n* Females can only participate if they have reached menopause, have had hysterectomy performed, use a coil as birthcontrol, or if they are sterilized.\n\nExclusion Criteria:\n\n* Presence of kidney disease, defined as S-creatinine \\>0,200 mmol/L.\n* Known lung or heart disease, defined as NYHA-class \\>2 or CCS-class \\>2.\n* Known allergic reactions to Rocuronium, Suxamethon, Propofol or Sugammadex.\n* Contraindications to Suxamethon. Including raised P-potassium (\\>5,0 mmol/L), untreated glaucoma, neuromuscular disorders or disposition to malignant hyperthermia.\n* Body mass index of \\>35 kg/m2.\n* Pregnant.\n* Breastfeeding.'}, 'identificationModule': {'nctId': 'NCT00953550', 'briefTitle': 'Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine', 'orgStudyIdInfo': {'id': '1B-RSI-SU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rocuronium-Sugammadex', 'interventionNames': ['Drug: Rocuronium-Sugammadex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Succinylcholine', 'interventionNames': ['Drug: Succinylcholine']}], 'interventions': [{'name': 'Rocuronium-Sugammadex', 'type': 'DRUG', 'otherNames': ['Esmeron', 'Bridion'], 'description': 'Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.', 'armGroupLabels': ['Rocuronium-Sugammadex']}, {'name': 'Succinylcholine', 'type': 'DRUG', 'otherNames': ['Suxameton', 'Suxamethon'], 'description': '1 mg/kg', 'armGroupLabels': ['Succinylcholine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Martin K Sørensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Lars Rasmussen', 'oldOrganization': 'Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet'}}}}