Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT03424356
Status:
UNKNOWN
Last Update Posted:
2018-06-13
First Post:
2017-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Low Dose Neuromuscular Blocker Usage on Laryngeal Mask Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D006993', 'term': 'Hypnotics and Sedatives'}, {'id': 'D003558', 'term': 'Cystoscopy'}], '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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2018-01-31', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'questionnaire', 'timeFrame': 'up to first 60 minutes', 'description': 'The quality of LMA placement with or without neuromusculer drug.'}], 'secondaryOutcomes': [{'measure': 'questionnaire', 'timeFrame': 'up to first 24 hours', 'description': 'after the surgery soar throat will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LMA', 'Rocuronium bromur', 'propofol'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Cystoscopy is a simple, effective and reliable method in current urological practice. Anesthesia may be required in cystoscopy for therapeutic purpose, however it may not be necessary for diagnostic cystoscopy. General anesthesia, spinal anesthesia, epidural anaesthesia and senile block methods may be performed in therapeutic cystoscopy.\n\nPain is main reason of failed cystoscopy. Sedo-analgesia and LMA are generally used for diagnostic cystoscopies. LMA is mostly placed under general anesthesia with the combination of propofol-fentanyl and volatile anesthetics. There is no need for muscle relaxant administration in LMA placement, as it is necessary for intubation. However if muscle relaxant is not used, side effects like hiccup, straining, cough, undesirable muscle movement, hypoxia and laryngeal spasm may be observed.\n\nFor the improvement of the patient comfort the use of effective muscle relaxants are described in several studies in literature. This study aimed to reveal the quality of anesthesia, hemodynamics, surgical comfort, extra propofol need and recovery time while low dose of muscle relaxant rocuronium was added to propofol-fentanyl combination for LMA placement.', 'detailedDescription': 'Cystoscopy is a simple, effective and reliable method in current urological practice for the diagnosis and treatment of urethral and bladder pathologies.\n\nProcedure is frequently used for the placement and replacement (removal) of double J stent in patients with ureteral stones .\n\nCystoscopy may be used for the investigation of hematuria and dysuria and if needed for diagnostic biopsy as well as for therapeutic purpose in patients with bladder and prostate tumor.\n\nAnesthesia may be required in cystoscopy for therapeutic purpose, however it may not be necessary for diagnostic cystoscopy. General anesthesia, spinal anesthesia, epidural anesthesia and senile block methods may be performed in therapeutic systoscopy. Diagnostic cystoscopies may be performed via sedoanalgesia, local anesthetic spray administration, penile block or without any type of anesthesia. Female patients having short urethra are more compatible for local techniques or for the procedures without anesthesia.\n\nPain is main reason of failed cystoscopy. Sedoanalgesia and LMA are generally used for diagnostic cystoscopies. LMA is mostly placed under general anesthesia with the combination of propofol-fentanyl and volatile anesthetics. There is no need for muscle relaxant administration in LMA placement, as it is necessary for intubation. However if muscle relaxant is not used, side effects like hiccup, straining, cough, undesirable muscle movement, hypoxia and laryngeal spasm may be observed. Placement of LMA may be difficult or sometimes impossible in some patients with limited mouth opening. These patients may experience complications like pain and burning in the mouth, pain in the ear, hoarse voice, swallowing difficulty because of difficult LMA placement in postoperative period.\n\nFor the improvement of the patient comfort the use of effective muscle relaxants are described in several studies in literature. This study aimed to reveal the quality of anesthesia, hemodynamics, surgical comfort, extra propofol need and recovery time while low dose of muscle relaxant rocuronium was added to propofol-fentanyl combination for LMA placement.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male patients\n2. ASA I-II patients\n3. Cystoscopy patients\n4. patients entubated with lariyngeal mask\n\nExclusion Criteria:\n\n1. Female patients\n2. Asa III-IV patients\n3. Surgery duration is more than 2 hours\n4. Drug abusers\n5. Non compromising patients'}, 'identificationModule': {'nctId': 'NCT03424356', 'briefTitle': 'Effects of Low Dose Neuromuscular Blocker Usage on Laryngeal Mask Application', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Comparison of Effects of Low Dose Neuromuscular Blocker Added to Propofol Fentanyl Combination During Lma Procedures in Cystoscopy Patients', 'orgStudyIdInfo': {'id': '2017/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lma with rocuronium bromide', 'description': 'In study group, 2-3 mg/kg propofol, 1mcg/kg fentanyl and 0.15 mg/kg rocuronium bromide will be administered during lma insertion in cystoscopy procedure.', 'interventionNames': ['Drug: Rocuronium Bromide', 'Drug: Fentanyl', 'Drug: Propofol', 'Procedure: cystoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lma with saline solution', 'description': 'In control group, 2-3 mg/kg propofol, 1 mcg/kg fentanyl and saline(no rocuronium) will be administered during lma insertion in cystoscopy procedure.', 'interventionNames': ['Drug: Saline Solution', 'Drug: Fentanyl', 'Drug: Propofol', 'Procedure: cystoscopy']}], 'interventions': [{'name': 'Rocuronium Bromide', 'type': 'DRUG', 'otherNames': ['nueromusculer blocker'], 'description': '0.15 mg/kg rocuronium bromide', 'armGroupLabels': ['lma with rocuronium bromide']}, {'name': 'Saline Solution', 'type': 'DRUG', 'otherNames': ['saline'], 'description': '1-2 ml saline solution', 'armGroupLabels': ['lma with saline solution']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['narcotic analgesic'], 'description': '1mcg/kg for induction', 'armGroupLabels': ['lma with rocuronium bromide', 'lma with saline solution']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['hypnotic agent'], 'description': '2-3mg/kg for anaesthetic induction', 'armGroupLabels': ['lma with rocuronium bromide', 'lma with saline solution']}, {'name': 'cystoscopy', 'type': 'PROCEDURE', 'otherNames': ['surgical prosedure'], 'description': 'patients will treated with this surgical procedure', 'armGroupLabels': ['lma with rocuronium bromide', 'lma with saline solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'mustafa asan, md', 'role': 'CONTACT', 'email': 'mustafaasan@yahoo.com', 'phone': '+905059352060'}, {'name': 'ayse ülgey, md', 'role': 'CONTACT', 'email': 'aülgey38@gmail.com', 'phone': '+905378201751'}], 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'mustafa asan, md', 'role': 'CONTACT', 'email': 'mustafaasan@yahoo.com', 'phone': '+905059352060'}, {'name': 'ayse ülgey, md', 'role': 'CONTACT', 'email': 'aülgey38@gmail.com', 'phone': '+905378201751'}], 'overallOfficials': [{'name': 'ayşe ülgey, md', 'role': 'STUDY_CHAIR', 'affiliation': 'TC Erciyes University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Ayse Ulgey', 'investigatorAffiliation': 'TC Erciyes University'}}}}