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

NCT06378645 | Recruiting Phase 4

• 1 other identifier: 2023-01682
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Erection; Incomplete

Keywords

transurethral surgery; penile tumescence; intraoperative erection; propofol; sevoflurane; investigator initiated trial

Outcome Measures

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.

  Assessment during the operation and reporting before the end of the surgery.

Secondary Outcomes (6)

• Prolongation of the surgery

  Assessment during the operation and reporting before the end of the surgery.

• Change in operative strategy

  Assessment during the operation and reporting before the end of the surgery.

• Adaptions of instruments or approaches

  Assessment during the operation and reporting before the end of the surgery.

• Altered operative outcome

  Assessment during the operation and reporting before the end of the surgery.

• Necessity for a drug application to decrease penile tumescence

  Assessment during the operation and reporting before the end of the surgery.

Study Arms (2)

Intervention group: Propofol

ACTIVE COMPARATOR

The patients in the intervention group are receiving a general anesthesia with Propofol.

Drug: General Anesthesia: Propofol

Control group: Sevoflurane

ACTIVE COMPARATOR

The patients in the control group are receiving a general anesthesia with Sevoflurane.

Drug: General Anesthesia: Sevoflurane

Interventions

General Anesthesia: Propofol DRUG

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.

Intervention group: Propofol

General Anesthesia: Sevoflurane DRUG

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.

Control group: Sevoflurane

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Etienne Xavier Keller: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

• Scherer TP, von Deschwanden C, Held U, Poyet C, Kwok JL, Kandler L, Schlapfer M, Keller EX, Schmid FA. Effect of Propofol Versus Sevoflurane on Erections during Narcosis in Transurethral Surgery: The PENIS Trial. Eur Urol Open Sci. 2024 Sep 24;69:100-104. doi: 10.1016/j.euros.2024.08.021. eCollection 2024 Nov.

  PMID: 39381594 DERIVED

Study Officials

• Etienne X Keller, Ass Prof, MD

  University Hospital Zurich, University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne X Keller, Ass Prof, MD

CONTACT

+41 44 255 54 40; EtienneXavier.Keller@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The authorized study nurse will hand the upcoming envelope with the treatment allocation to the anesthesiologist. The patient and the urologists (who is measuring the outcome) will not know which form of general anesthesia will be performed. Herewith, blankets in the operating room will hide installations used by the anesthesiologists to prevent the urologists witnessing the assigned narcosis form. Before the surgical sign-out, while still scrubbed in and with the patient under anesthesia, the anesthesiologists will ask the urologists about the outcome questionnaire. Together, they will fill in the paper case report form (CRF).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 22, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: After successful publishing
• Access Criteria: After successful publishing

Locations

CH (1)