jRCT1071240091招募中不适用
Efficacy and safety of nitrous oxide inhalation sedation/analgesia during strabismus surgery
未提供0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 主要终点
- pain sensation during surgery
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age 0month 0week old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients undergoing strabismus surgery under local anesthesia at the Ophthalmology Department of Nagasaki University Hospital
- •Patients aged 18 years or older (regardless of gender) at the time of obtaining consent
- •Patients who have received a full explanation of their participation in this study, fully understood the study, and have given their own voluntary written consent
排除标准
- •Patients with severe respiratory or circulatory diseases
- •Patients currently undergoing an asthma attack or with a history of severe asthma
- •Patients with vitamin B12 deficiency
- •Patients with impaired hematopoietic function
- •Patients with closed cavities in the body, such as tubal obstruction, pneumothorax, ileus, or pneumocephalus
- •Patients after ophthalmic surgery in which gases used for tamponade (perfluoropropane, sulfur hexafluoride, etc.) are present in the vitreous
- •Pregnant women
- •Patients currently participating in clinical trials or other clinical research
- •Patients who are otherwise deemed inappropriate as research subjects by the principal investigator
结局指标
主要结局
pain sensation during surgery
时间窗: during surgery
疼痛感觉
presence or absence of nausea and vomiting
恶心和呕吐的有无
次要结局
- sedation due to nitrous oxide
- presence or absence of symptoms
- Transcutaneous oxygen saturation(start, during the operation, and at the end)
- non-invasive blood pressure (systolic blood pressure, diastolic blood pressure)(start, during the operation, and at the end)
- pulse rate(start, during the operation, and at the end)
- respiratory rate(start, during the operation, and at the end)
- Side effects
- pain sensation during eye washing
研究者
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