Comparing Propofol and Sevoflurane for Managing Erections During Urological Surgery
Prospective, Randomized-Controlled Study of the Effect of Propofol vs. Sevoflurane on Erections During Narcosis in Transurethral Surgery
PHASE4 · University of Zurich · NCT06378645
This study is testing whether using propofol or sevoflurane as anesthesia during urological surgery affects the chances of having unwanted erections and if it leads to more complications for patients.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | University of Zurich (other) |
| Locations | 1 site (Zurich) |
| Trial ID | NCT06378645 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two anesthetic agents, propofol and sevoflurane, on the occurrence of unwanted penile erections during transurethral surgeries. It aims to determine whether the use of propofol, which has been associated with a higher incidence of intraoperative erections, leads to more complications compared to sevoflurane. The research will involve patients scheduled for transurethral operations, assessing their experiences and outcomes based on the type of anesthesia used. The study is crucial as it addresses a gap in existing literature regarding the impact of anesthesia on intraoperative events.
Who should consider this trial
Good fit: Ideal candidates are adult males scheduled for transurethral surgery with a preoperative IIEF-5 score of 12 or higher.
Not a fit: Patients with contraindications to propofol or sevoflurane, or those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia protocols that minimize unwanted intraoperative erections, enhancing surgical outcomes and patient comfort.
How similar studies have performed: While there is limited high-quality evidence on this topic, previous studies have indicated varying rates of intraoperative erections with different anesthetic agents, suggesting that this area warrants further investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zurich
- University Hospital Zurich — Zurich, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Etienne X Keller, Ass Prof, MD — University Hospital Zurich, University of Zurich
- Study coordinator: Etienne X Keller, Ass Prof, MD
- Email: EtienneXavier.Keller@usz.ch
- Phone: +41 44 255 54 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Erection, Incomplete, transurethral surgery, penile tumescence, intraoperative erection, propofol, sevoflurane, investigator initiated trial