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Recruiting Phase 4 NCT06378645

Effect of Propofol vs. Sevoflurane on Erections During Narcosis In Transurethral Surgery

Trial Parameters

Condition Erection; Incomplete
Sponsor Etienne Xavier Keller
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 200
Sex MALE
Min Age 18 Years
Max Age 75 Years
Start Date 2024-02-01
Completion 2026-12-01
Interventions
General Anesthesia: PropofolGeneral Anesthesia: Sevoflurane

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Planned transurethral operation in the department of urology. * Preoperative IIEF-5 Score ≥12 * Planned surgery time ≥15min Exclusion Criteria: * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. * Inability to provide informed consent. * Contraindications to Propofol or Sevoflurane, e.g. known hypersensitivity or allergy. * Known or suspected non-compliance, drug or alcohol abuse. * Participation in another study with an investigational drug within the 30 days preceding and during the present study. * Previous enrolment into the current study. * Enrolment of the investigator, his/her family members, employees and other dependent persons.

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