Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT06216002
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2023-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Train of four nerve stimulation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 622}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of residual neuromuscular blockade', 'timeFrame': '0-30 minute after surgery', 'description': 'Incidence of residual neuromuscular blockade with the relation of frailty after gynecologic oncology surgery'}, {'measure': 'Incidence of frailty', 'timeFrame': '0 - 24 hours preoperative', 'description': 'Incidence of frailty in patients undergoing gynecologic oncology surgery'}], 'secondaryOutcomes': [{'measure': 'Anesthetic technique used', 'timeFrame': 'Throughout Intraoperative period, an average 3-5 hours', 'description': 'Anesthetic technique used in patients undergoing gynecologic oncology surgery'}, {'measure': 'Rate of blood transfusion', 'timeFrame': 'Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative', 'description': 'Quantity of units blood transfusion'}, {'measure': 'Rate of vasopressor usage', 'timeFrame': 'Throughout Intraoperative period, an average 3-5 hours to 24 hours postoperative', 'description': 'Rate of vasopressor usage eg. ephedrine, norepinephrine'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Through study completion, an average of 1 year, an average 3 - 5 days', 'description': 'Total number of days of hospital stay'}, {'measure': 'Rate of intensive care unit admission', 'timeFrame': '0 - 24 hours postoperative', 'description': 'Number of patients who require intensive care unit admission after surgery'}, {'measure': 'Rate of re-intubation', 'timeFrame': '0 - 24 hours postoperative', 'description': 'Number of patients who require re-intubation'}, {'measure': 'Rate of postoperative mechanical ventilation', 'timeFrame': '0 - 24 hours postoperative', 'description': 'Number of patients who require mechanical ventilation postoperative'}, {'measure': 'Rate of postoperative pulmonary complications', 'timeFrame': '3 days after operation', 'description': 'Number of patients who have postoperative pulmonary complications eg. prolonged intubation, atelectasis, pneumonia etc.'}, {'measure': 'Mortality rate', 'timeFrame': '30 days after operation', 'description': 'Number of patients who died after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neuromuscular blocking agents', 'frailty', 'gynecologic oncology', 'surgery', 'anesthetic complications'], 'conditions': ['Frailty', 'Neuromuscular Blockade', 'General Anesthetic Drug Adverse Reaction', 'Gynecologic Cancer', 'Surgical Complication']}, 'descriptionModule': {'briefSummary': 'Frailty among patients undergoing surgery is strongly associated with an elevated risk of adverse perioperative outcomes, heightened incidence of postoperative complications, increased mortality rates, and prolonged hospital length of stay. Our focus centers on investigating the frailty index in the context of complications experienced by patients undergoing oncologic gynecology surgery. The principal objective of this research is to elucidate the extent to which residual neuromuscular blocking agents are linked to frailty.', 'detailedDescription': 'Among patients undergoing oncologic gynecological procedures, such as those for vulvar cancer, endometrial cancer, and ovarian cancer, the incidence of frailty has been observed to range from 14% to 45%. Frailty directly influences the metabolism of anesthetic agents and intraoperative management. Furthermore, the prevalence of residual neuromuscular blocking agents following surgery can be as high as 26% to 53%. No prior research has investigated the correlation between residual muscle relaxants and frailty in gynecologic oncology patients. This study is designed to assess the prevalence of residual muscle relaxants in these patients with frailty. Additionally, data on the incidence of frailty and its impact on postoperative outcomes and prognosis in patients undergoing gynecologic oncology surgery will be collected and reported.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>,= 18 years\n* Patients undergoing elective gynecologic-oncology surgery\n\nExclusion Criteria:\n\n* Unable to communicate Thai\n* Unable to understand the questionnaire\n* Preexisting neuromuscular disease\n* Preexisting disease involved wrist that may affect the nerve stimulator examination'}, 'identificationModule': {'nctId': 'NCT06216002', 'acronym': 'FIGO', 'briefTitle': 'Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Incidence of Residual Neuromuscular Blockade in Patients With Frailty Undergoing Gynecologic Cancer Surgery', 'orgStudyIdInfo': {'id': '599/2566(IRB3)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOF nerve stimulation', 'description': 'Patient receive TOF nerve stimulation in recovery room after surgery', 'interventionNames': ['Diagnostic Test: Train of four nerve stimulator']}], 'interventions': [{'name': 'Train of four nerve stimulator', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patient receive nerve stimulation by TOF-scan equipment at recovery room after surgery.', 'armGroupLabels': ['TOF nerve stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Patchareya Nivatpumin, M.D.', 'role': 'CONTACT', 'email': 'kook27602@gmail.com', 'phone': '+662-419-7000', 'phoneExt': '7990'}, {'name': 'Nutthavit Hantayapong, M.D.', 'role': 'CONTACT', 'email': 'koh25008@hotmail.com', 'phone': '+6681-925-0538'}, {'name': 'Patchareya Nivatpumin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Anesthesiology department, Siriraj hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Patchareya Nivatpumin, M.D.', 'role': 'CONTACT', 'email': 'patchareya.niv@mahidol.ac.th', 'phone': '+66896662187'}, {'name': 'Jitsupa Nithiuthai, M.D.', 'role': 'CONTACT', 'email': 'jitsupa.nit@mahidol.ac.th', 'phone': '+66661466594'}], 'overallOfficials': [{'name': 'Patchareya Nivatpumin, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University'}, {'name': 'Jitsupa Nithiuthai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}