RecruitingPhase 4NCT06378645

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

Prospective, Randomized-Controlled Study of the Effect of Propofol vs. Sevoflurane on Erections During Narcosis in Transurethral Surgery


Sponsor

Etienne Xavier Keller

Enrollment

200 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • Planned transurethral operation in the department of urology.
  • Preoperative IIEF-5 Score ≥12
  • Planned surgery time ≥15min

Exclusion Criteria7

  • 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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Interventions

DRUGGeneral Anesthesia: Propofol

Transurethral surgery at the Department of Urology (University Hospital Zurich) performed under study arm-specific anesthesia. Propofol will be administered intravenously using the target-controlled infusion algorithm with effect site concentrations between 1.5-4.0 µg/ml necessary.

DRUGGeneral Anesthesia: Sevoflurane

Transurethral surgery at the Department of Urology (University Hospital Zurich) performed under study arm-specific anesthesia. Sevoflurane will be given in gaseous form via the endotracheal tube in concentrations between 1.5-2.5% Vol.


Locations(1)

University Hospital Zurich

Zurich, Switzerland

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NCT06378645