Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-08 @ 10:27 PM
Study NCT ID:
NCT06847659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-26
First Post:
2025-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing Holmium Laser Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to onset of intraoperative hypothermia.', 'timeFrame': 'intraoperatively', 'description': 'Time to develop intraoperative hypothermia (when body temperature drops below 36°C)'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic parameters', 'timeFrame': 'intraoperatively', 'description': 'heart rate'}, {'measure': 'Volume of irrigation fluid used', 'timeFrame': 'intraoperatively', 'description': 'Volume of irrigation fluid used'}, {'measure': 'Changes in body temperature', 'timeFrame': 'intraoperatively', 'description': 'Changes in preoperative and intraoperative body temperature'}, {'measure': 'Hemodynamic parameters', 'timeFrame': 'intraoperatively', 'description': 'mean arterial pressure'}, {'measure': 'respiratory parameter', 'timeFrame': 'intraoperatively', 'description': 'SpO2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prewarming', 'Holmium Laser Prostate Surgery', 'Hypothermia Following Anesthesia']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of prewarming methods in preventing intraoperative hypothermia in patients undergoing HoLEP surgery. Designed as a randomized controlled study, patients who receive prewarming will be compared with those in the control group.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged 18 years and older\n* Patients undergoing HoLEP surgery under general anesthesia\n* Patients who consent to participate in the study\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study.\n* Patients unable to read, understand, or sign the informed consent form.\n* Hemodynamically unstable patients.\n* Patients with a preoperative or intraoperative body temperature \\>37°C.'}, 'identificationModule': {'nctId': 'NCT06847659', 'briefTitle': 'Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing Holmium Laser Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing HoLEP (Holmium Laser Prostatectomy) Surgery', 'orgStudyIdInfo': {'id': 'TABED1-24-841'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prewarming Group', 'description': 'Patients will receive 10 minutes of 43°C forced-air warming and 41°C prewarmed intravenous fluid before surgery. Surgery will begin following the standard induction of general anesthesia once patients are in the operating room. An air blower set to 43°C will maintain patient warmth throughout the procedure.', 'interventionNames': ['Diagnostic Test: intraoperative body temperature']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'No prewarming will be applied. Surgery will begin following the standard induction of general anesthesia once patients are in the operating room. An air blower set to 43°C will maintain patient warmth throughout the procedure.', 'interventionNames': ['Diagnostic Test: intraoperative body temperature']}], 'interventions': [{'name': 'intraoperative body temperature', 'type': 'DIAGNOSTIC_TEST', 'description': 'Body temperature measurement with esophageal probe', 'armGroupLabels': ['Control Group', 'Prewarming Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital Bilkent', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Betül Güven Aytaç, Assoc.prof.', 'role': 'CONTACT', 'email': 'drbguven@hotmail.com', 'phone': '+905073578351'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ankara City Hospital Bilkent', 'investigatorFullName': 'Betül Güven', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}