Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-01 @ 2:42 PM
Study NCT ID:
NCT06794450
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2025-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery Times of Half Dose Sugammadex and Neostigmine for Rocuronium-induced Neuromuscular Blockade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D001285', 'term': 'Atropine'}], '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'}, {'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': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-25', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery time', 'timeFrame': '1 hour', 'description': 'This refers to the duration measured from the point at which a Train-of-Four Count (TOFC) of 2 is observed, indicating the administration of the reversal agent, to the achievement of a Train-of-Four Ratio (TOFR) of 90%.\n\nTrain of four is a electrical stimulus pattern that describe the neuromuscular blockade depth. Acceleromyography device used to monitor the neuromuscular blockade depth. Train of Four count (TOFC) 1-3 counted as moderate neuromuscular blockade, train of count (TOFC) 0 counted as deep neuromuscular blockade, train of four count (TOFC) 4 until train of four ratio (TOFR) 89% counted as mild or minimal neuromuscular blockade, and train of four ratio (TOFR) 90% counted as adequate recovery'}], 'secondaryOutcomes': [{'measure': 'Spontaneous recovery time of rocuronium', 'timeFrame': '3 hours', 'description': "This refers to the duration measured from the administration of rocuronium to the achievement of a Train-of-Four Count (TOFC) of 1 and 2\n\nAfter administration of rocuronium, subject will undergo deep neuromuscular blockade with train of four count 0. Rocuronium will undergo spontaneous degradation over a certain period, but it depends on the body's response to diffusion, redistribution, metabolism, excretion, and release from the muscle relaxant receptors. The duration from the administration of rocuronium, which causes deep neuromuscular blockade with a TOFC depth of 0, to the achievement of moderate neuromuscular blockade with TOFC depths of 1 and 2 will be measured."}, {'measure': 'Bradycardia', 'timeFrame': '1 hour', 'description': 'Assess the frequency of bradicardia after the reversal agent administered'}, {'measure': 'Hypotension', 'timeFrame': '1 hour', 'description': 'Assess the frequency of hypotension (mean arterial pressure under 65) after the administration of reversal agent'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sugammadex', 'Neostigmine', 'recovery time from neuromuscular blockade'], 'conditions': ['Neuromuscular Blocking Agents', 'Reversal of Neuromuscular Blockade', 'Recovery Time']}, 'descriptionModule': {'briefSummary': 'In operating procedure with general anesthesia muscle relaxant is usually used to increase success rate of the operation and to give better outcome. The use of reversal drugs aims to reduce the risk of post-operative complications due to muscle relaxants. Neostigmine is commonly used as a reversal drug, but its indirect mechanism of action results in a long and unpredictable recovery time. Sugammadex directly bind and inactivate rocuronium, in which resulting in a faster and predictable recovery time. However, the high price limits the use of sugammadex.\n\nThis study aims to compare the effect of half dose sugammadex and neostigmine against the moderate neuromuscular blockade of rocuronium.\n\nThe main questions it aims to answer are:\n\nDoes half dose sugammadex gives faster recovery time? Researchers will compare sugammadex to neostigmine to see if sugammadex gives faster recovery time.\n\nParticipants will:\n\nBe given sugammadex or neostigmine as a reversal drug after the operation done', 'detailedDescription': "Neuromuscular blocking agents are frequently utilized to facilitate tracheal intubation, minimize the risk of vocal cord injury, suppress patient movement, and ensure optimal ventilation. The administration of these agents, along with meticulous monitoring of neuromuscular blockade depth, plays a critical role in optimizing the success rates and minimizing complications associated with various surgical procedures, including laparotomy and laparoscopic abdominal surgeries.\n\nAt the conclusion of surgery, when muscle relaxation is no longer required, neuromuscular blockade should be reversed promptly, safely, and reliably using appropriate reversal agents to minimize the risk of postoperative complications associated with residual neuromuscular blockade. A study reported that 64% of patients undergoing general anesthesia exhibited a neuromuscular recovery of less than 90% and experienced symptoms of re-curarization in the recovery room.\n\nVarious reversal agents are available to counteract the effects of neuromuscular blockade, utilizing either direct or indirect mechanisms of action. Cholinesterase inhibitors, such as neostigmine, are among the most commonly used agents. They act indirectly by inhibiting acetylcholinesterase, thereby preventing the breakdown of acetylcholine at the neuromuscular junction. However, this mechanism is reliant on the individual's acetylcholine production rate, which can limit neostigmine's effectiveness, contributing to its unpredictability, and increase the risk of re-curarization. In contrast, sugammadex is a specialized reversal agent designed specifically to counteract neuromuscular blockade induced by rocuronium. Unlike neostigmine, sugammadex employs a direct mechanism by encapsulating rocuronium molecules and forming an inactive complex. This approach enables a faster onset of action and provides a more consistent and predictable recovery profile.\n\nThe utilization of sugammadex in Indonesia remains relatively limited, despite the frequent use of rocuronium as a muscle relaxant. This limited use is largely attributed to the significantly higher cost of sugammadex compared to neostigmine. Nonetheless, research has demonstrated that even at doses lower than the recommended levels, sugammadex achieves faster recovery times compared to neostigmine in reversing neuromuscular blockade induced by rocuronium. This trial looks forward to answering the recovery time of half-dose recommended sugammadex compared with neostigmine with usual dose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent laparoscopic cholecystectomy under general anesthesia\n* Using muscle relaxant rocuronium\n* Aged 18-59 years\n* American Society of Anesthesiologists (ASA) physical status classification of 1 or 2.\n\nExclusion Criteria:\n\n* History of drug allergies to the agents used\n* Renal dysfunction\n* Musculoskeletal disorders\n* Central nervous system disorders\n* Difficult airways requiring intubation without the use of muscle relaxants.'}, 'identificationModule': {'nctId': 'NCT06794450', 'briefTitle': 'Recovery Times of Half Dose Sugammadex and Neostigmine for Rocuronium-induced Neuromuscular Blockade', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Padjadjaran'}, 'officialTitle': 'Comparison of Recovery Times Between 1 mg/kg Sugammadex and 60 mcg/kg Neostigmine for Moderate Neuromuscular Blockade Induced by Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AN-202412.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugammadex', 'description': 'The subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant Rocuronium.\n\nAt the end of the surgery, thirty patients will be administered Sugammadex 1 mg/kg as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%.', 'interventionNames': ['Drug: Sugammadex 1 mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neostigmine', 'description': 'The subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant rocuronium.\n\nAt the end of the surgery, thirty patients will be administered Neostigmine 60 mcg/kg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%.', 'interventionNames': ['Drug: Neostigmine + Atropine']}], 'interventions': [{'name': 'Sugammadex 1 mg/kg', 'type': 'DRUG', 'description': 'Patient in experimental arms will receive i.v. sugammadex 1 mg/kg at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed', 'armGroupLabels': ['Sugammadex']}, {'name': 'Neostigmine + Atropine', 'type': 'DRUG', 'description': 'Patient in active comparators arms will receive i.v. neostigmine 60 mcg/kg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed', 'armGroupLabels': ['Neostigmine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40161', 'city': 'Bandung', 'state': 'West Java', 'status': 'RECRUITING', 'country': 'Indonesia', 'facility': 'Hasan Sadikin General Hospital', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}], 'centralContacts': [{'name': 'Rivan P Rivan Putra Afewa, M.D., M.D.', 'role': 'CONTACT', 'email': 'rivan.chaniago@gmail.com', 'phone': '+6285316832464'}], 'overallOfficials': [{'name': 'Tini T Maskoen, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine Universitas Padjadjaran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Padjadjaran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}