Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT05517551
Status:
UNKNOWN
Last Update Posted:
2022-08-26
First Post:
2022-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Low and Normal Flow Anesthesia in Robotic Assisted Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2022-08-23', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inspiratory O₂ concentration', 'timeFrame': 'from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)', 'description': 'inspiratory O₂ concentration is measured from anesthesia machine monitor'}, {'measure': 'partial oxygen pressure', 'timeFrame': 'from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)', 'description': 'PO2 from blood gas analysis'}], 'secondaryOutcomes': [{'measure': 'desflurane consumption', 'timeFrame': 'perioperative', 'description': 'desflurane consumption at the end of anesthesia is measured from anesthesia machine monitor'}, {'measure': 'changes in liver and kidney function tests from the preoperative values to 48 hours postoperative', 'timeFrame': 'during operation and 48 hours postoperative', 'description': 'to determine the changes in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine from the preoperative values to 48 hours postoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Flow Anesthesia', 'Normal Flow Anesthesia', 'Robotic Surgery']}, 'descriptionModule': {'briefSummary': 'Robot-assisted laparoscopic radical prostatectomy has gained increasing popularity compared to open radical prostatectomy with its advantages such as low blood loss, reduced blood transfusion rate, low complication rate, and shortened hospital stay. Since robot-assisted laparoscopic radical prostatectomy should be performed in the limited retroperitoneal area, insufflation of the abdomen with carbon dioxide (CO2) (pneumoperitoneum) and steep Trendelenburg position are required to provide better surgical vision.\n\nLow-flow anesthesia warms and moistens the inhaled gases, creating a more physiological breathing atmosphere during anesthesia. In addition, it provides cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. Studies show that long-term minimal flow anesthesia is safe and advantageous for non-laparoscopic surgery.\n\nThe aim of this study is to compare low-flow (1L/min) with normal flow (3lt/min) desflurane anesthesia in terms of hemodynamic and respiratory parameters, inhalation agent consumption and soda lime consumption for robotic assisted laparoscopic radical prostatectomy surgery.\n\nThe secondary aim of the study is to compare the effects of low-flow and normal-flow anesthesia in the steep trendelenburg position (45°) used for robotically assisted laparoscopic radical prostatectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who will undergo robotic-assisted laparoscopic prostatectomy surgery', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- ASA I-II risk group\n\nExclusion Criteria:\n\n* ASA III, IV, V,\n* concomitant serious cardiac, respiratory, hepatic, renal disturbance,\n* mental status disorder and hearing problem,\n* anxiety and depression and/or other psychiatric disorders,\n* patient's refusal"}, 'identificationModule': {'nctId': 'NCT05517551', 'briefTitle': 'Comparison of Low and Normal Flow Anesthesia in Robotic Assisted Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'The Effect of Low-flow and Normal-flow Desflurane Anesthesia on Respiratory Parameters in Robotic-assisted Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'E1-22-2755'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal flow anesthesia', 'description': 'A fresh gas flow of 3 L/min will be applied continuously', 'interventionNames': ['Procedure: robotic assisted radical prostatectomy']}, {'label': 'low flow anesthesia', 'description': 'A fresh gas flow of 3 L/min will be applied for the first 20 minutes after intubation , and then it will be reduced to 1 L/min.', 'interventionNames': ['Procedure: robotic assisted radical prostatectomy']}], 'interventions': [{'name': 'robotic assisted radical prostatectomy', 'type': 'PROCEDURE', 'description': 'Patients who will undergo robotic-assisted laparoscopic prostatectomy surgery', 'armGroupLabels': ['low flow anesthesia', 'normal flow anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'betül güven aytaç, MD', 'role': 'CONTACT', 'email': 'drbguven@hotmail.com', 'phone': '05073578351'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Betül Güven', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}