protocolSection identificationModule nctId: NCT06378645, orgStudyIdInfo id: 2023-01682, briefTitle: Effect of Propofol vs. Sevoflurane on Erections During Narcosis In Transurethral Surgery, acronym: PENIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Etienne Xavier Keller, class: OTHER, descriptionModule briefSummary: Penile erection is an unwanted event in transurethral (through the urethra) surgeries, which may be associated with adverse outcomes such as impaired access, prolonged operation time, the need to abort the operation, or the necessity for ancillary measures to achieve penile flaccidity, such as the injection of certain medications directly into the penis.To reduce greenhouse gas emissions, the primary use of propofol instead of gaseous agents is being recommended for general anesthesia. Whether propofol may be associated with an increased or decreased rate of unwanted intraoperative penile erection compared to other anesthetic agents is not known. More generally, there are no high-quality studies available to evaluate the impact of the type of general anesthesia on the risk of unwanted penile erections during surgery.This study aims to determine whether general anesthesia with propofol is more likely to cause intraoperative erections compared to sevoflurane during transurethral operations., conditionsModule conditions: Erection; Incomplete, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: The authorized study nurse will hand the upcoming envelope with the treatment allocation to the anesthesiologist. The patient and the urologists (who is measuring the outcome) will not know which form of general anesthesia will be performed. Herewith, blankets in the operating room will hide installations used by the anesthesiologists to prevent the urologists witnessing the assigned narcosis form. Before the surgical sign-out, while still scrubbed in and with the patient under anesthesia, the anesthesiologists will ask the urologists about the outcome questionnaire. Together, they will fill in the paper case report form (CRF)., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: General Anesthesia: Propofol, interventions name: General Anesthesia: Sevoflurane, outcomesModule primaryOutcomes measure: Intraoperative Penile Erection, secondaryOutcomes measure: Prolongation of the surgery, secondaryOutcomes measure: Change in operative strategy, secondaryOutcomes measure: Adaptions of instruments or approaches, secondaryOutcomes measure: Altered operative outcome, secondaryOutcomes measure: Necessity for a drug application to decrease penile tumescence, secondaryOutcomes measure: Complications arisen, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zurich, status: RECRUITING, city: Zürich, zip: 8091, country: Switzerland, contacts name: Etienne X Keller, Ass Prof, MD, role: CONTACT, phone: +41 44 255 54 40, email: etiennexavier.keller@usz.ch, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False