Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-02-25 @ 8:41 PM
Study NCT ID:
NCT01996358
Status:
SUSPENDED
Last Update Posted:
2017-04-04
First Post:
2013-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013390', 'term': 'Succinylcholine'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2013-11-22', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '72 hours after intervention', 'description': 'measurement on a numeric ten point scale'}], 'primaryOutcomes': [{'measure': 'Intubating Condition', 'timeFrame': 'after induction of general anaesthesia (after 3-5 minutes)', 'description': 'The intubating conditions will be measured using the scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting the rigid bronchoscope, vocal cord position and coughing'}], 'secondaryOutcomes': [{'measure': 'Postoperative Myalgia', 'timeFrame': '72 hours after intervention', 'description': 'The severity of POM is measured by using a four-point-scale:\n\n0\\. no myalgia\n\n1. minor pain limited to one area of the body\n2. muscle pain or stiffness noticed spontaneously by the patient, which may have required analgesic therapy\n3. generalized, severe or incapacitating discomfort'}]}, 'conditionsModule': {'keywords': ['Succinylcholine', 'Rocuronium', 'Rigid Bronchoscopy'], 'conditions': ['Intubating Conditions', 'Postoperative Myalgia', 'Patient Satisfaction']}, 'descriptionModule': {'briefSummary': 'Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM) as well as patient satisfaction for these two muscle relaxants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 yr\n* scheduled for elective rigid bronchoscopy\n\nExclusion Criteria:\n\n* known neuromuscular disease\n* significant hepatic or renal dysfunction\n* family history of malignant hyperthermia\n* known allergy to one of the drugs used in this protocol\n* pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT01996358', 'briefTitle': 'Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Horst Schmidt Klinik GmbH'}, 'officialTitle': 'Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study', 'orgStudyIdInfo': {'id': 'HSK004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Succinylcholine', 'description': 'Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy', 'interventionNames': ['Drug: Succinylcholine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rocuronium 0,3', 'description': 'Rocuronium 0,3 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.', 'interventionNames': ['Drug: Rocuronium 0,3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rocuronium 0,6', 'description': 'Rocuronium 0,6 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.', 'interventionNames': ['Drug: Rocuronium 0,6']}], 'interventions': [{'name': 'Succinylcholine', 'type': 'DRUG', 'description': 'Anaesthesia is induced and maintained with propofol (1-2 mg/kg) and remifentanil (0,5 µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. After induction of anaesthesia the patient receives muscle relaxant according to the study group.', 'armGroupLabels': ['Succinylcholine']}, {'name': 'Rocuronium 0,3', 'type': 'DRUG', 'description': 'General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.', 'armGroupLabels': ['Rocuronium 0,3']}, {'name': 'Rocuronium 0,6', 'type': 'DRUG', 'description': 'General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.', 'armGroupLabels': ['Rocuronium 0,6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65199', 'city': 'Wiesbaden', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Dr. Horst Schmidt Klinik', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Grietje Beck, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Dr. Horst Schmidt Klinik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Horst Schmidt Klinik GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med', 'investigatorFullName': 'Prof. Grietje Beck', 'investigatorAffiliation': 'Dr. Horst Schmidt Klinik GmbH'}}}}