NCT07618676进行中（未招募）不适用
The 50:50 Nitrous Oxide Challenge: A Prospective Randomised Trial - Needle, Meet Your Match
Institute for Oncology and Radiology of Serbia2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年6月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 2
研究概览
简要总结
The main goal of the project is to assess pain levels and patient comfort during the administration of a 50:50 Nitrous Oxide/Oxygen gas mixture, in comparison to the same parameters under the standard method used at our institution, which includes injecting a local anaesthetic at the site of planned puncture for central venous catheterisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have not previously received Nitrous Oxide.
- •Subjects of both sexes, aged between 18 and 65 inclusive.
- •Subjects who have signed informed consent with full disclosure; no study-related procedure may begin until the subject signs the consent form.
排除标准
- •Infection at the planned puncture site.
- •Pregnancy.
- •Intracranial hypertension.
- •Vitamin B12 deficiency.
- •Hemodynamic instability.
- •Glasgow Coma Scale (GCS) score less than
- •Presence of chronic pain.
- •Neurological disorders.
- •Hematologic disorders.
- •Systemic or intrathecal methotrexate therapy
- •More than two attempts at venous puncture (Subject Withdrawal Criterion).
- •Subject experienced an adverse event requiring early discontinuation (Subject Withdrawal Criterion).
- •Withdrawal of consent by the subject (Subject Withdrawal Criterion)
研究组 & 干预措施
Nitrous Oxide Group
Experimental
This will be the experimental group in which the patients will receive a mixture of gases to assess the efficacy of the treatment compared to the control.
干预措施: Nitrous Oxide-Oxygen (Drug)
Lidocaine 2%
Active Comparator
The control group receiving the standard of care for this intervention.
干预措施: Lidocaine 2% Injectable Solution (Drug)
研究者
Ana Cvetković
Head of the Department of Anesthesia
Institute for Oncology and Radiology of Serbia
研究点 (2)
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