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Идёт набор NCT07245628

A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy

Ранняя фаза I С лечением Vasectomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nitrous Oxide, Oxygen.
Кому может быть актуально
Состояния в реестре: Vasectomy. Базовые параметры: 18 лет — 85 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Single-Blind Randomized Placebo Controlled Trial of Self-Adjusted Nitrous Oxide During Office Vasectomy

Обзор

The goal of this clinical trial is to see if nitrous oxide is safe and effective to use during during vasectomies performed in a clinic/in-office setting. This trial will compare self-administered nitrous oxide versus a placebo (oxygen) during office vasectomy. The main questions it aims to answer are: * Whether self-administered low dose (20-45%) nitrous oxide (SANO) reduces intraoperative anxiety and catastrophizing during office vasectomy. * To examine whether SANO reduces intraoperative pain or alters procedure duration, the rate of adverse events, or urologists' perception of ease and patient tolerance of the procedure. Participants will be asked to complete multiple surveys pre-procedure, intra-procedure, and post-procedure.

Вмешательства

  • Препарат Nitrous Oxide
    Self-Administered Nitrous Oxide
  • Препарат Oxygen
    Self-Administered Oxygen

Первичные конечные точки

  • Mean Difference in VAS-A During Vasectomy Procedure and S-PCS Immediately After Vasectomy Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [Срок оценки: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)]
Вторичные конечные точки (6)
  • Mean Difference in Visual Analog Scale for Pain (VAS-P) Intra-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [Срок оценки: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Intra-Procedure (In Between Left and Right Sides of Procedure)]
  • Mean Difference in VAS-P and STAI Pre- and Post-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [Срок оценки: Pre-Procedure (Day of Procedure, Immediately Prior) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)]
  • Mean Difference in 30-Day Complications / Adverse Events, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [Срок оценки: Study Enrollment - 30 Days After Vasectomy]
  • Urologist: Ease of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [Срок оценки: Post-Procedure, Day of Vasectomy]
  • Urologist: Patient Tolerance, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [Срок оценки: Post-Procedure, Day of Vasectomy]
  • Mean Difference in Duration of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [Срок оценки: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)]

Критерии участия

Критерии включения

  • Age 18 - 85 at the time of screening
  • Desiring vasectomy for family planning purposes
  • Able to understand and complete patient questionnaires
  • Willing and able to provide written consent to participate in the study

Критерии исключения

  • Patients with unilateral absence of the vas deferens
  • Patients who are deemed by study surgeons to have anatomy no amendable for office procedure
  • Patients who decline office vasectomy and request monitored anesthesia care
  • Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure
  • Patients with contraindications to nitrous oxide including:
  • Inner ear, bariatric, or eye surgery within the past 2 weeks
  • Current emphysematous blebs
  • Severe B-12 deficiency
  • History of bleomycin chemotherapy within the last year
  • Class III or higher heart failure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT07245628 · 2025P000258

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗