Effect of Propofol vs. Sevoflurane on Erections During Narcosis In Transurethral Surgery
ConditionErection; Incomplete
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-75
SponsorEtienne Xavier Keller
About this trial
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
This trial does not accept healthy volunteersQualifiers
Planned transurethral operation in the department of urology.
Preoperative IIEF-5 Score ≥12
Planned surgery time ≥15min
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
General Anesthesia: Propofol
DrugTransurethral 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.
General Anesthesia: Sevoflurane
DrugTransurethral 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Intervention group: PropofolActive comparator 1 intervention
Group B: Control group: SevofluraneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative Penile Erection
The primary endpoint "penile erection" will be analyzed as a binary outcome flaccid or erect. The occurrence of an erect penis at any time during surgery is classified as erect penile tumescence. Flaccid penile tumescence is classified only if erect penile tumescence does not occur at any point during the operation. The beginning and end of the operation are defined as the first insertion and last retrieval of all instruments, respectively. The penile tumescence will be reported in a simplified version of the validated EHS (erection hardness score): 0: flaccid, 1: increased tumescence, but not fully erect, 2: full erection. Erect penile tumescence is defined as achieving a score of either 1 or 2, whereas flaccid penile tumescence is defined as a score of 0.
Time frame
Assessment during the operation and reporting before the end of the surgery.Secondary outcomes
1
Prolongation of the surgery
The treating urologist will answer a questionnaire specifying if there was a subjective prolongation of the surgery (yes (time)/no).
Time frame
Assessment during the operation and reporting before the end of the surgery.2
Change in operative strategy
The treating urologist will answer a questionnaire specifying if there was a change in operative strategies due to penile tumescence (yes/no).
Time frame
Assessment during the operation and reporting before the end of the surgery.3
Adaptions of instruments or approaches
The treating urologist will answer a questionnaire immediately after the surgery specifying if there were adaptions of instruments or approaches due to penile tumescence (yes/no).
Time frame
Assessment during the operation and reporting before the end of the surgery.4
Altered operative outcome
The treating urologist will answer a questionnaire specifying if there was a change of the operative outcome due to penile tumescence (yes/no).
Time frame
Assessment during the operation and reporting before the end of the surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Etienne Xavier Keller
Lead sponsor
University of Zurich
Sponsor institution
Source ClinicalTrials.gov