Prospective, Randomized-Controlled Study of the Effect of Propofol vs. Sevoflurane on Erections During Narcosis in Transurethral Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Intraoperative Penile Erection
研究概览
简要总结
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.
详细描述
Introduction
Intraoperative penile erection is an unwanted event during transurethral surgery, since it may impair the access to the urinary pathways thus prolonging operation time and sometimes requiring ancillary measures to reach penis flaccidity. Ultimately, penile erections may cause operation abortion. Fortunately, reversal of penile erections can be achieved intraoperatively by pharmacological interventions such as intravenous administration of ketamine or intracorporeal injection of vasoactive agents such as phenylephrine or epinephrine, although these medications are in turn associated with potentially severe secondary effects. The incidence of intraoperative penile erections is reported to lay between 2.2% and 3.5% in adults. The evidence on the topic is of limited quality, thus the risk factors and frequency of unwanted penile erections in transurethral interventions remain to be evaluated.
The use of propofol has been associated with a particularly high risk for sexual arousal and intraoperative erections, reaching an incidence of unwanted erections of up to 10% in pediatric case series undergoing urethral surgery. The causes and the pathophysiology have been partially explored, although the leading mechanisms remain debated.
In an effort to reduce greenhouse gas emissions, the primary use of propofol instead of gaseous agents for general anesthesia has been introduced at our tertiary academic hospital in October 2022. This institutional change in anesthesia protocol has led to a perceived increase in the rates of unwanted intraoperative erections and interventions to achieve penile flaccidity, possibly associated with the increased use of propofol. Because there are no high-quality studies investigating the impact of various anesthetic agents on penile tumescence in men during transurethral procedures in literature to date, anesthesiologist and urologist at our institution initiated together a prospective randomized controlled trial comparing the incidence of intraoperative penile tumescence during propofol versus sevoflurane general anesthesia.
Sample size determination
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Planned transurethral operation in the department of urology.
- •Preoperative IIEF-5 Score ≥12
- •Planned surgery time ≥15min
排除标准
- •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.
研究组 & 干预措施
Intervention group: Propofol
The patients in the intervention group are receiving a general anesthesia with Propofol.
干预措施: General Anesthesia: Propofol (Drug)
Control group: Sevoflurane
The patients in the control group are receiving a general anesthesia with Sevoflurane.
干预措施: General Anesthesia: Sevoflurane (Drug)
结局指标
主要结局
Intraoperative Penile Erection
时间窗: Assessment during the operation and reporting before the end of the surgery.
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.
次要结局
- Prolongation of the surgery(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.)
- Adaptions of instruments or approaches(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.)
- Altered operative outcome(Assessment during the operation and reporting before the end of the surgery.)
- Complications arisen(Assessment for 24 hours after the surgery.)
研究者
Etienne Xavier Keller
Assistant Professor
University of Zurich