白内障监测麻醉护理 (MAC) 可行性试点研究 (CaTNAPS-1)
2026年6月11日 更新者：University of California, San Francisco
比较白内障手术程序镇静的两种常规方法：一项前瞻性、可行性试点研究
这项试点临床试验的目的是比较两种不同的白内障手术镇静方法，评估患者满意度、康复质量和手术结果，并评估研究方案的总体可行性和可接受性，以便规划更大规模的研究方案。临床试验。
在整个研究过程中，参与者将被要求回答多项关于他们的经历的调查，并评估感兴趣的结果。
研究概览
详细说明
这是一项单中心、随机、双盲试点临床试验（n=10）。
首次接受白内障手术的参与者将随机接受口服苯二氮卓类药物（干预）或口服安慰剂药丸（对照）。
本研究的主要目标是比较接受口服镇静剂与口服安慰剂进行白内障手术的参与者在患者满意度、恢复质量和手术结果方面的差异。
本研究的次要目标是评估招募成功率、干预保真度、干预措施的依从性以及干预后参与者的保留率。
将要求参与者在关键研究时间点对有关其镇静体验的多项调查做出回应，并评估感兴趣的结果。
研究类型
介入性
注册 (实际的)
23
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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San Francisco、California、美国、94143
- University of California, San Francisco
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
纳入标准：
- ≥65岁
- 能够提供知情同意书并用英语完成研究程序
- 能够为自己提供同意
- 能够遵循指示
- 能够爬一层楼梯而不需要停下来休息
- 白内障疾病的新诊断
- 计划在未来 6 个月内进行眼睛白内障手术
排除标准：
- 既往白内障手术史
- 过去 30 天内入院记录
- 在其他小型门诊手术或影像学检查期间难以镇静
- 对局部麻醉剂过敏或耐药
- 在没有症状的情况下无法平躺（即呼吸困难、严重背痛等）
- 需要常规使用苯二氮卓类药物的严重焦虑史
- 严重瓣膜疾病（例如严重主动脉瓣狭窄）
- 需要植入心脏装置的心脏病，例如起搏器、除颤器或左心室辅助装置（用于心律失常、充血性心力衰竭等）
- 未经治疗的胸痛或心绞痛
- 患有运动障碍的患者（例如帕金森病）
- 脑血管意外 (CVA)、短暂性脑缺血发作 (TIA) 或癫痫病史
- 休息或劳累时需要家用氧气 (O2)
- 需要透析的终末期肾病 (ESRD)
- 病态肥胖（BMI>35）
- 接受白内障手术并结合任何其他眼科手术的患者
- 由于现有白内障的基本特征和/或计划手术的预期复杂性，在白内障手术期间需要全身麻醉的患者
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：干涉
手术前将给患者口服镇静剂。
|
术前口服抗焦虑药物
|
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安慰剂比较：安慰剂
手术前将给患者服用口服安慰剂药丸。
|
术前服用不含活性成分的安慰剂药丸
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With High Satisfaction (ISAS Score ≥ 2)
大体时间：30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction. For this analysis, high satisfaction is defined as an ISAS score ≥ 2. |
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants Meeting Eligibility Criteria at Screening
大体时间：At screening (prior to enrollment)
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Number of participants who met all eligibility criteria at the time of screening, out of the total number of participants assessed for eligibility
|
At screening (prior to enrollment)
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Number of Participants Completing All Study Surveys at Each Timepoint
大体时间：30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
Number of participants who completed all required study surveys at each postoperative timepoint (PACU, POD1, POD7), out of the number of participants assigned to each study arm
|
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
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Number of Participants Who Completed All Required Study Procedures
大体时间：From enrollment through final study follow-up (POD7)
|
Number of participants who completed all required study procedures from enrollment through the final postoperative follow-up visit, out of the total number of participants enrolled in the study Instruments: Iowa Satisfaction with Anesthesia Scale (ISAS) Postoperative Quality of Recovery Scale (PQRS) Quality of Recovery-15 (QoR-15) Functional Recovery Index (FRI) |
From enrollment through final study follow-up (POD7)
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Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up
大体时间：From enrollment through 30 days after surgery
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Number of participants experiencing at least one sedation-related complication within 30 days after surgery, out of the total number of participants enrolled in the study
|
From enrollment through 30 days after surgery
|
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Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS)
大体时间：30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
The Postoperative Quality of Recovery Scale (PQRS) assesses recovery across physiological, pain, emotional, cognitive, and activities of daily living domains. For this analysis, recovery is defined as meeting PQRS recovery criteria at each time point. Recovery is defined as a return to baseline performance in all assessed PQRS domains at each time point. |
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
|
Quality of Recovery-15 (QoR-15) Total Score After Surgery
大体时间：1 day and 7 days after surgery
|
The Quality of Recovery-15 (QoR-15) is a validated 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, psychological support, and physical independence.
Each item is scored from 0 to 10, and the total score is calculated by summing all items, resulting in a total score range of 0 to 150.
Higher scores indicate better recovery.
|
1 day and 7 days after surgery
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Functional Recovery Index (FRI) Total Score After Surgery
大体时间：1 day and 7 days after surgery
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The Functional Recovery Index (FRI) is a validated 14-item questionnaire assessing postoperative functional recovery, including mobility and activities of daily living.
Each item is scored and summed to produce a total score ranging from 0 to 100.
Lower scores indicate better functional recovery.
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1 day and 7 days after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Catherine L Chen, M.D.、University of California, San Francisco
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年6月12日
初级完成 (实际的)
2025年5月6日
研究完成 (实际的)
2025年5月29日
研究注册日期
首次提交
2024年6月25日
首先提交符合 QC 标准的
2024年7月11日
首次发布 (实际的)
2024年7月17日
研究记录更新
最后更新发布 (实际的)
2026年7月9日
上次提交的符合 QC 标准的更新
2026年6月11日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.