Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT07191769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Importance of Anesthesia Method in Fragile Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative morbidity', 'timeFrame': '30-day postoperative morbidity', 'description': 'Morbidity rates up to the 30th day postoperatively will be recorded. Patients will be contacted by phone and the data will be recorded.'}, {'measure': 'Postoperative mortality', 'timeFrame': '30-day postoperative mortality', 'description': 'Mortality rates up to the 30th day postoperatively will be recorded. Patients will be contacted by phone and the data will be recorded.'}], 'secondaryOutcomes': [{'measure': 'intraoperative complications,', 'timeFrame': 'perioperative period', 'description': 'In the study, complications that develop during surgery (arrhythmia etc.), whether the surgical time differs between the two groups, and the length of hospital stay will be recorded.'}, {'measure': 'Duration of surgery', 'timeFrame': 'Until the end of the surgery', 'description': 'The surgical durations of patients in both groups will be recorded in the study.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'first week after surgery', 'description': 'The length of time the patient stays in hospital for the operation will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['frail patient', 'general anaesthesia', 'regional anaesthesia'], 'conditions': ['Frail Elderly Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to comparatively evaluate the effects of different anaesthesia methods (spinal anaesthesia and general anaesthesia) administered to frail elderly patients scheduled for transurethral surgery (e.g. TUR-Prostate or TUR-Bladder) on postoperative morbidity and mortality rates.', 'detailedDescription': 'When planning transurethral surgery in frail patients, optimising the anaesthesia method is critical in minimising perioperative risks. In a 2021 study by Darwish et al. (1), 28,486 TUR-P cases were grouped according to the selected anaesthesia method. The 30-day mortality rate was 0.4% in the neuroaxial anaesthesia (spinal/epidural) group and 0.7% in the general anaesthesia group; the neuroaxial anaesthesia group showed significantly better outcomes in terms of secondary morbidity rates such as mortality and sepsis. However, there are studies in the literature supporting general anaesthesia. A study by Ayoub et al. (4) emphasised that in frail patients, similar morbidity rates can be achieved with general anaesthesia or spinal anaesthesia; spinal anaesthesia may increase the risk of hypotension and bradycardia. Based on these studies, the selection of the appropriate anaesthesia method for transurethral procedures is of critical importance in terms of patient morbidity and mortality rates. This study aims to contribute to clinical guidelines by clarifying which type of anaesthesia is safer in this specific demographic and clinical group. Within the scope of the research, parameters such as complications associated with the anaesthesia method, length of hospital stay, readmission rate, and 30-day mortality are analysed with the aim of determining the most appropriate and safest anaesthesia method for the vulnerable patient group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 65 years and older who are scheduled for transurethral surgery (such as TUR-P or TUR-M), meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in the study. A validated frailty score (FRAIL Survey) will be used for frailty assessment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly patients aged 65 and over\n* ASA (American Society of Anaesthesiologists) physical condition classification I-III patients\n* meeting the criteria for frailty\n\nExclusion Criteria:\n\n* Non-elective emergency surgeries\n* Patients under 65 years of age\n* Patients classified as ASA Class IV\n* Patients unable to provide informed consent due to cognitive impairment\n* Patients who have previously undergone major neurological or cardiac surgery'}, 'identificationModule': {'nctId': 'NCT07191769', 'briefTitle': 'The Importance of Anesthesia Method in Fragile Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'The Effect of the Selected Anaesthesia Method on Morbidity and Mortality in Frail Patients Scheduled for Transurethral Surgery', 'orgStudyIdInfo': {'id': 'SBU-ANESTEZİ-DMY-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing general anaesthesia', 'description': 'Patients aged 65 years and older who are scheduled for transurethral surgery, meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in this group after being enrolled in the study and undergoing general anaesthesia.', 'interventionNames': ['Procedure: general anaesthesia']}, {'label': 'Patients undergoing regional anaesthesia', 'description': 'Patients aged 65 years and older who are scheduled for transurethral surgery, meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in this group after being enrolled in the study and undergoing regional anaesthesia.', 'interventionNames': ['Procedure: regional anaesthesia']}], 'interventions': [{'name': 'general anaesthesia', 'type': 'PROCEDURE', 'description': 'Patients undergoing general anaesthesia', 'armGroupLabels': ['Patients undergoing general anaesthesia']}, {'name': 'regional anaesthesia', 'type': 'PROCEDURE', 'description': 'Patients undergoing regional anaesthesia', 'armGroupLabels': ['Patients undergoing regional anaesthesia']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dilek MD Metin Yamac', 'role': 'CONTACT', 'email': 'ddilekmetin@hotmail.com', 'phone': '05054959792'}, {'name': 'Dilek M Yamac', 'role': 'CONTACT', 'email': 'ddilekmetin@hotmail.com', 'phone': '05054959792'}], 'overallOfficials': [{'name': 'Dilek Yamac', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sultan Abdülhamid Han education and research hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}