Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-02-02 @ 8:53 AM
Study NCT ID:
NCT06228092
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2023-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-05', 'size': 507267, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-10T08:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2024-01-18', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Episodes of desaturation', 'timeFrame': 'During the period of the PACU stay', 'description': 'Occurrence of episodes of desaturation defined as more than 3 minutes with spO2 \\< 88%.'}, {'measure': 'New cardiac arrythmias', 'timeFrame': 'Within 180 minutes after administration of reversal agent', 'description': 'Occurrence of new cardiac arrythmias (bradycardia or tachycardia defined as atrial fibrillation, atrial flutter, sinus tachycardia (\\>95 bpm), sinus bradycardia (\\<45 bpm))'}, {'measure': 'Airway obstruction', 'timeFrame': 'During the period of the PACU stay', 'description': 'Occurrence of upper airway obstruction'}, {'measure': 'Reintubation', 'timeFrame': 'During the period of the PACU stay', 'description': 'Occurrence of reintubation'}], 'primaryOutcomes': [{'measure': 'Time to TOF > 0.9', 'timeFrame': 'first TOF ratio ≥ 0.9 (time until complete recovery from effect of muscle relaxant) followed by a stable signal with a TOF ratio ≥ 0.9 for at least two minutes.', 'description': 'time to TOF ≥ 0.9 after administration of either sugammadex or neostigmine/glycopyrrolate'}], 'secondaryOutcomes': [{'measure': 'Residual muscular blockade', 'timeFrame': 'Assessed upon arrival at PACU, after 20 minutes at PACU and after 90 minutes at PACU', 'description': 'Sign of residual muscular blockade defined as a composite (assessed upon arrival at PACU) of either:\n\nhand grip strength for 5 seconds; occurrence of double vision/blurred vision (yes/no); ability to track objects with eyes (follow finger of examiner) (yes/no); ability to sustain head lift for 5 seconds (yes/no); ability to protrude the tongue for 5 seconds (yes/no); tongue depressor test (prevent removal of a wooden tongue depressor from between the incisor teeth (yes/no); ability to open the eyes for 5 seconds (yes/no); ability to smile (yes/no); ability to speak (yes/no); occurrence of dysphagia/ swallowing impairment (ability to drink 20 ml of water) (yes/no); occurrence of upper airway obstruction; subjective symptoms of muscle weakness (whether the patient think a test was difficult to complete or uncomfortable to perform), recorded as normal (negative response) or impaired (positive response)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromuscular Blockade, Residual']}, 'referencesModule': {'references': [{'pmid': '41307280', 'type': 'DERIVED', 'citation': 'Vested M, Wadland SS, Christensen MI, Creutzburg A, Madsen KPD, Tsuchiya EA, Madsen BG, Rovsing ML, Meyhoff CS, Lindelof K, Afshari A, Rasmussen LS. Neostigmine Versus Sugammadex for Reversal of Neuromuscular Blockade in Elderly Patients: A Blinded Randomised Study. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70160. doi: 10.1111/aas.70160.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the time to TOF ≥ 0.9 after either neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg in patients with age ≥ 75 years. The hypothesis of this study is that sugammadex 2 mg/kg provides a faster time to TOF ≥ 0.9 compared to neostigmine/glycopyrrolate 50 mikrogr/kg.', 'detailedDescription': 'Numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications.\n\nAlthough the use of neuromuscular blocking agents (NMBAs) to improve surgical condition are still debated, they are routinely administered in the clinical setting during anesthesia both to facilitate tracheal intubation and impair the surgical conditions. However, elderly patients administered NMBAs during anesthesia have an increased risk of postoperative residual neuromuscular block which is associated with more frequent episodes of hypoxemia, postoperative pulmonary complications, discomfort and longer hospital length of stay.\n\nTo prevent postoperative residual block it is strongly recommended to employ neuromuscular monitoring perioperatively, performed by train-of-four (TOF) stimulation, which enables the anesthetist to titrate the depth of block and to reverse the block if spontaneous recovery has not occurred upon conclusion of surgery.\n\nIt is possible to reverse rocuronium induced neuromuscular blockade with either neostigmine/glycopyrrolate (an acetylcholine esterase inhibitor) or sugammadex (a modified cyclodextrin). However, the optimal choice of reversal agent for rocuronium induced neuromuscular blockade in elderly patients is unknown. There is a need for studies investigating which reversal agent is optimal in elderly patients.\n\nThis randomized, parallel group trial will compare neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg for reversal of rocuronium induced blockade in elderly patients (≥ 75 years) undergoing robot surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ≥ 75 years old\n2. Informed consent\n3. Scheduled for robotic assisted laparoscopic surgery under general anesthesia with intubation and use of rocuronium during the entire operation\n4. American Society of Anesthesiologists (ASA) physical status classification I to IV\n5. Can read and understand Danish\n\nExclusion Criteria:\n\n1. Known allergy to rocuronium, sugammadex or neostigmine/glycopyrrolate\n2. Neuromuscular disease that may interfere with neuromuscular data\n3. Severe renal impairment defined as eGFR \\< 30 ml/min\n4. Indication for rapid sequence induction\n5. Known intestinal or ureter obstruction\n6. Known peritonitis'}, 'identificationModule': {'nctId': 'NCT06228092', 'briefTitle': 'Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'A Blinded Randomized Study of Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients (≥ 75 Years)', 'orgStudyIdInfo': {'id': '2023-504230-21-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'neostigmine/glycopyrrolate group', 'description': 'neostigmine/glycopyrrolate 50 mikrogr/kg', 'interventionNames': ['Drug: neostigmine/glycopyrrolate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sugammadex group', 'description': 'Sugammadex 2 mg/kg', 'interventionNames': ['Drug: Sugammadex']}], 'interventions': [{'name': 'neostigmine/glycopyrrolate', 'type': 'DRUG', 'otherNames': ['Robinul-Neostigmin'], 'description': 'Anesthesia personnel will administer the drug as a bolus over 5 seconds in an intravenous catheter upon conclusion of anaesthesia with a TOF within the range from TOF count of 2 to a TOF ratio \\< 0.60', 'armGroupLabels': ['neostigmine/glycopyrrolate group']}, {'name': 'Sugammadex', 'type': 'DRUG', 'otherNames': ['Bridion'], 'description': 'Anesthesia personnel will administer the drug as a bolus over 5 seconds in an intravenous catheter upon conclusion of anaesthesia with a TOF within the range from TOF count of 2 to a TOF ratio \\< 0.60', 'armGroupLabels': ['Sugammadex group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2830', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of anaesthesia, Centre of Head and Orthopedics, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Pediatric and Obstetric Anaesthesia, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Matias Vested, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matias Vested', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D.', 'investigatorFullName': 'Matias Vested', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}