Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P)
研究概览
简要总结
This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.
详细描述
Patients scheduled for vasectomy at Beth Israel Deaconess Medical Center will be contacted and offered enrollment in the study. Vasectomy will occur according to standard-of-care and all participants will receive the typical lidocaine injections at the beginning of the procedure. Before the start of the vasectomy, a study staff member will help participants put on a plastic gas mask and demonstrate how to turn the gas up or down using the remote control. Nitrous oxide and oxygen will be given through a plastic mask. A remote control given to participants will allow them to adjust the nitrous oxide based on their comfort. The Nitrouseal® machine used in this study limits nitrous oxide to concentrations to "minimal sedation" (0-50%), which are levels where a person remains awake and is able to talk and breath normally.
Before the day of a participant's vasectomy, they will be asked questions related to demographics and medical history to determine study eligibility. Immediately before and after vasectomy, participants will be asked to describe their anxiety and pain levels. At two-weeks and three-months after vasectomy, a brief electronic survey will be sent to participants' email asking about recollection of pain and anxiety and satisfaction with the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Scheduled for vasectomy
- •Aged 21 to 85 years
- •Suitable for receipt of inhaled nitrous oxide/oxygen
- •Access to an email and computer
排除标准
- •Perioral facial hair impeding good mask seal
- •Cognitive impairment that impedes ability to complete survey questions
- •Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy
- •Has any of the following medical conditions, which contraindicate use of nitrous oxide:
- •Inner ear, bariatric or eye surgery within the last 2 weeks,
- •Current emphysematous blebs,
- •Severe B-12 deficiency,
- •Bleomycin chemotherapy within the past year,
- •Heart attack within the past year,
- •Stroke within the past year,
- •Class III or higher heart failure.
研究组 & 干预措施
Self-adjusted nitrous oxide (SANO)
All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.
干预措施: Nitrous oxide (Drug)
结局指标
主要结局
Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P)
时间窗: Measured immediately after completion of vasectomy
Level of pain experienced during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
次要结局
- Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P)(Measured immediately prior to vasectomy)
- Emergent adverse events as assessed by frequency of incidents(Measured during and up to 30 days after day of vasectomy)
- Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)(Measured immediately after completion of vasectomy)
- Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P)(Measured two weeks and three months after vasectomy)
- Operator ease of performing vasectomy(Measured immediately after urologist finishes vasectomy)
- Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P)(Measured two weeks and three months after vasectomy)
- Satisfaction assessed by Likert scale(Measured during and two weeks after vasectomy)
- Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)(Measured immediately prior to vasectomy)
研究者
Heidi Rayala
Assistant Professor of Surgery
Beth Israel Deaconess Medical Center