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Study comparing different types of general anesthesia and their influence on erection during minimally invasive surgery in urology (PENIS trial)

Minimally invasive urological operations are often performed via the urethra. In men, a spontaneous erection can occur during general anesthesia, making access difficult or even making the operation impossible. If this is the case, the general anesthesia must be adjusted or an adrenaline-like medication must be administered directly into the erectile tissue of the penis. Erections during general anesthesia occur irregularly, and the reasons for this are still unknown. To date, there have been no studies on how often and under what circumstances such erections occur and whether the type of anesthesia could promote or even cause them.

Aim of the study

In this study, we are investigating how often an erection occurs when using the drugs propofol or sevoflurane for general anesthesia. Both drugs have proven to be safe for general anesthesia and have been used daily at the University Hospital Zurich for many decades.

Target group

Patients who
  • are between 18 and 75 years old
  • undergo endo-urological, transurethral surgery (via the urethra) lasting at least 15 minutes. lasts
  • achieve at least 12 points on the IIEF-5 questionnaire before the operation.

Procedure

Participation in the study is voluntary and will not take longer than the planned therapy. There are no additional appointments. We will find out whether you meet the inclusion criteria using the IIEF-5 questionnaire, which we will give you during your consultation. The IIEF-5 is a simple but reliable questionnaire developed for the assessment of erectile function in men. You will be informed about the study by both the urologist and the anesthesiologist. If you would like to participate, you will sign the informed consent form and will be randomly assigned to a study group before the operation. There are two groups: - Group 1 is given general anesthesia with propofol. - Group 2 receives general anesthesia with sevoflurane Both study drugs have been approved for anesthesia in Switzerland for over 20 years and have been used daily at the USZ for minimally invasive urological procedures for a long time. The study is double-blind. Neither the patient nor the urologist know which group the participants are assigned to in order to keep the results as unbiased as possible. The study ends for you with the follow-up visit on the day of the operation or on the following day at the latest. You can also withdraw your consent to participate in the study at any time beforehand without giving reasons.

Compensation

You will not receive any compensation. However, you will not incur any additional costs.

Original study name

Prospective, randomized study of the Effect of Propofol vs. Sevoflurane on erections during narcosis in endourological surgery

BASEC number

2023-01682

Financial support from

Responsible Department