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

NCT06378645 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-04-22

No results posted yet for this study

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

Interventions

DRUG

General 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.

DRUG

General 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.

Sponsors & Collaborators

  • Etienne Xavier Keller

    lead OTHER

Principal Investigators

  • Etienne X Keller, Ass Prof, MD · University Hospital Zurich, University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06378645 on ClinicalTrials.gov