Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-02-01 @ 8:31 AM
Study NCT ID:
NCT07003061
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sarcopenia and Neuromuscular Block in Gastrointestinal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-05-26', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset Time of Neuromuscular Block', 'timeFrame': 'Intraoperative (from induction until adequate block is achieved)', 'description': 'Time from administration of the muscle relaxant to achievement of adequate neuromuscular block, measured by Train-of-Four (TOF) monitoring.'}, {'measure': 'Depth of Neuromuscular Block (TOF Ratio)', 'timeFrame': 'Intraoperative (from induction to end of surgery)', 'description': 'Intraoperative depth of neuromuscular block, continuously monitored using TOF ratio.'}, {'measure': 'Duration of Neuromuscular Block', 'timeFrame': 'Intraoperative (from muscle relaxant administration to recovery)', 'description': 'Time from administration of the muscle relaxant to recovery of neuromuscular function (TOF ratio ≥ 0.9).'}, {'measure': 'Dose and Duration of Reversal Agent', 'timeFrame': 'Intraoperative (from administration of reversal agent to recovery)', 'description': 'Total dose and time required for the reversal agent to achieve recovery from neuromuscular block.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Cancer', 'Sarcopenia', 'Neuromuscular Blockade']}, 'referencesModule': {'references': [{'pmid': '40197883', 'type': 'BACKGROUND', 'citation': 'Almeida PS, Barao K, Forones NM. SARCOPENIA AND GASTROINTESTINAL CANCER: NUTRITIONAL APPROACH FOCUSING ON CURCUMIN SUPPLEMENTATION. Arq Gastroenterol. 2025 Apr 4;62:e24068. doi: 10.1590/S0004-2803.24612024-068. eCollection 2025.'}, {'pmid': '30734824', 'type': 'BACKGROUND', 'citation': 'Clark BC. Neuromuscular Changes with Aging and Sarcopenia. J Frailty Aging. 2019;8(1):7-9. doi: 10.14283/jfa.2018.35.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to evaluate the effects of sarcopenia on intraoperative neuromuscular block (NMB) in patients undergoing gastrointestinal cancer surgery. Adult patients scheduled for elective gastrointestinal cancer surgery will be grouped as sarcopenic or non-sarcopenic based on preoperative abdominal CT scans. Neuromuscular block parameters, including onset time, depth, duration, and recovery, will be objectively measured using TOF (Train-of-Four) monitoring. The study seeks to determine whether sarcopenia influences sensitivity to muscle relaxants and to contribute to individualized anesthesia management and patient safety.', 'detailedDescription': 'Sarcopenia, characterized by the loss of skeletal muscle mass and function, is a significant clinical parameter affecting both prognosis and perioperative management in patients with gastrointestinal (GI) cancer. It may alter the pharmacokinetic and pharmacodynamic properties of anesthetic agents, particularly neuromuscular blocking agents. This prospective observational study will be conducted at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between June 1, 2025, and September 1, 2025.\n\nAdult patients (aged 18 and above) scheduled for elective GI cancer surgery who have undergone preoperative abdominal computed tomography (CT) will be included. Patients with neuromuscular diseases, those on chronic steroid or immunosuppressive therapy, or those with significant organ failure will be excluded. Preoperative CT images at the L3 vertebral level will be evaluated by a radiologist to determine sarcopenia status, and patients will be divided into sarcopenic and non-sarcopenic groups according to established cut-off values.\n\nAll patients will receive standard anesthesia monitoring, including TOF (Train-of-Four) neuromuscular monitoring. The study will not alter any treatment protocols. After administration of muscle relaxants during anesthesia induction, neuromuscular block parameters such as onset time, depth, duration, need for reversal agents, and recovery time will be recorded. Demographic data, comorbidities, laboratory findings, type of surgery, and details of muscle relaxant use will also be collected.\n\nThe primary objective is to compare intraoperative neuromuscular block parameters between sarcopenic and non-sarcopenic patients. Statistical analysis will be performed using appropriate parametric or non-parametric tests for continuous variables and chi-square tests for categorical variables. The study aims to provide evidence for individualized dosing of muscle relaxants and to improve patient safety in anesthesia practice for GI cancer surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 18 to 75 years who have been diagnosed with gastrointestinal cancer and are scheduled for elective surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. All participants will have undergone preoperative abdominal CT scans. Both male and female patients meeting the inclusion and exclusion criteria will be eligible for enrollment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 75 years\n* Patients diagnosed with gastrointestinal system (GIS) cancer and scheduled for elective surgery\n* Patients who have undergone preoperative abdominal computed tomography (CT) imaging\n* Patients classified as American Society of Anesthesiologists (ASA) physical status I-III\n\nExclusion Criteria:\n\n* Patients with a history of neuromuscular diseases\n* Patients receiving chronic steroid or immunosuppressive therapy\n* Patients with electrolyte imbalance\n* Patients using medications that affect neuromuscular transmission\n* Patients with severe organ failure in the preoperative period (e.g., liver or renal failure)\n* Patients who refuse to participate in the study\n* Patients requiring emergency surgery\n* Patients using muscle relaxants in the preoperative period'}, 'identificationModule': {'nctId': 'NCT07003061', 'briefTitle': 'Sarcopenia and Neuromuscular Block in Gastrointestinal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}, 'officialTitle': 'The Effects of Sarcopenia on Neuromuscular Block in Gastrointestinal Cancer Surgery', 'orgStudyIdInfo': {'id': '2025-05/79'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sarcopenic', 'description': 'Patients with gastrointestinal cancer scheduled for elective surgery who are identified as sarcopenic based on preoperative abdominal CT scans at the L3 vertebral level, according to established cut-off values.', 'interventionNames': ['Procedure: Standard Anesthesia Management']}, {'label': 'Non-Sarcopenic', 'description': 'Patients with gastrointestinal cancer scheduled for elective surgery who are identified as non-sarcopenic based on preoperative abdominal CT scans at the L3 vertebral level, according to established cut-off values.', 'interventionNames': ['Procedure: Standard Anesthesia Management']}], 'interventions': [{'name': 'Standard Anesthesia Management', 'type': 'PROCEDURE', 'description': 'All patients will receive standard anesthesia care as per institutional protocols. No experimental intervention will be applied.', 'armGroupLabels': ['Non-Sarcopenic', 'Sarcopenic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Ankara', 'state': 'Yenimahalle', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mustafa Kemal SAHIN, Dr', 'role': 'CONTACT', 'email': 'mksahin@msn.com', 'phone': '+905075800976'}, {'name': 'Eda Caferoglu, Dr', 'role': 'CONTACT', 'email': 'edacennet.95@gmail.com'}], 'facility': 'Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Mustafa Kemal SAHIN', 'role': 'CONTACT', 'email': 'mksahin@msn.com', 'phone': '+905075800976'}], 'overallOfficials': [{'name': 'Mustafa Kemal SAHIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation'}, {'name': 'Mensure KAYA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation'}, {'name': 'Belkis YILMAZ', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation'}, {'name': 'Ahmet BAYRAK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Oncology Education and Research Hospital Clinic of Radiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified individual participant data (IPD) will be made available upon reasonable request after publication of the study results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mustafa Kemal ŞAHİN', 'investigatorAffiliation': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}}}}