Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT04854993
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2021-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery From dNMB Using Different Sugammadex Doses in Elderly Patients Undergoing Robot-assisted Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient as well as the investigator (care provider) who will administer the different blinded sugammadex dosage and collect postoperative data will be blinded to the group allocation. The randomization and preparation of the drug will be performed by the unblinded staff of hospital experimental pharmacy who will carry out the randomization with a 1: 1 ratio and will assign the different dose to each patient. The drug will be prepared in a shielded pre-filled syringe in order to maintain blindness. In case of emergency, the pharmacy staff will immediately open the randomization code of interest disclosing the group assignment (sugammadex dose).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuromuscular recovery time', 'timeFrame': '5 minutes', 'description': 'Time from the end of sugammadex administration to train-of-four (TOF)=1'}], 'secondaryOutcomes': [{'measure': 'Time to extubation', 'timeFrame': '10 minutes', 'description': 'Time from neuromuscular reversal (TOF=1) to extubation'}, {'measure': 'Time to OR exit', 'timeFrame': '30 minutes', 'description': 'Time from neuromuscular reversal (TOF=1) to exit from the operating room'}, {'measure': 'PACU length of stay', 'timeFrame': '2 hours', 'description': 'Duration of stay in the post-anaesthesia care unit'}, {'measure': 'Hemodynamic parameters', 'timeFrame': 'up to discharge from post-anaesthesia care unit, an average of 2 hours', 'description': 'Non-invasive blood pressure (mmHg) and heart rate (beats per minute) after sugammadex administration'}, {'measure': 'Respiratory function', 'timeFrame': 'up to discarge from post-anaesthesia care unit, an average of 2 hours', 'description': 'Peripheral oxygen saturation (percentage) and respiratory rate (breaths per minute) after sugammadex administration'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sugammadex', 'elderly', 'recovery time', 'robotic surgery'], 'conditions': ['Prostate Cancer', 'Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': 'The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Secondary objectives are to evaluate the different extubation time, time to exit from the operating room (OR), lenght of stay in post-anaesthesia care unit (PACU) and safety (hemodynamic parameters and respiratory function).', 'detailedDescription': 'An increasing percentage of elderly patients with localized prostate cancer undergo RALP, due to the higher safety and feasibility of this minimally invasive surgical option compared to standard open procedure. This procedure is performed under deep neuromuscular block (dNMB) in order to guarantee an adequate working space. Induction and maintenance of the dNMB require neuromuscular monitoring and adequate reversal at the end of the intervention to prevent postoperative residual curarization (PORC). Sugammadex is the most attractive strategy to titrate reversal according to NMB monitoring data and to ensure a complete recovery of muscle function before extubation. In elderly patients, the risk of PORC and related postoperative complications is higher. For these reasons, we hypothesize that a dose of sugammadex increased by 50% compared to a standard dose could significantly shorten neuromuscular recovery time, extubation time, OR discharge time and PACU length of stay in elderly patients undergoing RALP.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient's age ≥65years\n* prostate cancer\n* robot-assisted laparoscopic radical prostatectomy (RALP)\n\nExclusion Criteria:\n\n* inability to obtain written informed consent\n* history of significant liver, renal or pulmonary diseases\n* current smoking\n* chronic or acute alcoholism\n* known or suspected neuromuscular disorders\n* family history of malignant hyperthermia\n* any pre-existing coagulopathy\n* abnormal blood coagulation tests (including prothrombin time \\<70%; activated partial thromboplastin time \\>38 seconds and INR \\>1.20) or preoperative anticoagulant therapies\n* BMI ≥30 Kg/m2\n* known allergy or hypersensitivity to the drugs used in the study\n* planned postoperative admission to intensive care unit.\n* moderate neuromuscular block (TOF 1-3) at the end of surgery"}, 'identificationModule': {'nctId': 'NCT04854993', 'acronym': 'RECIR', 'briefTitle': 'Recovery From dNMB Using Different Sugammadex Doses in Elderly Patients Undergoing Robot-assisted Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Recovery From Deep Neuromuscular Blockade Using Different Sugammadex Doses in Elderly Patients Undergoing Laparoscopic Robot-assisted Prostatectomy: a Prospective, Randomized, Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': '3764'}, 'secondaryIdInfos': [{'id': '2020-004704-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Increased dose of sugammadex', 'description': 'A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery', 'interventionNames': ['Drug: Sugammadex 6 mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dose of sugammadex', 'description': 'A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery', 'interventionNames': ['Drug: Sugammadex 4 mg/kg']}], 'interventions': [{'name': 'Sugammadex 6 mg/kg', 'type': 'DRUG', 'otherNames': ['MK-8616'], 'description': 'i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB', 'armGroupLabels': ['Increased dose of sugammadex']}, {'name': 'Sugammadex 4 mg/kg', 'type': 'DRUG', 'otherNames': ['MK-8616'], 'description': 'i.v. injection of a standard dose of sugammadex to reverse dNMB', 'armGroupLabels': ['Standard dose of sugammadex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Paola Aceto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}