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Consent Understanding and Propofol Requirement During Endobronchial Ultrasound

2026年8月24日 更新者：Gökçe Kızılkale Kayıkcı、Uludag University

Association of Preoperative Consent Understanding With Propofol Requirement During Endobronchial Ultrasound: A Prospective Observational Study

The goal of this observational study is to learn whether a participant's understanding of the informed consent information is related to the amount of propofol needed during endobronchial ultrasound (EBUS). EBUS is a procedure that uses a thin camera and ultrasound to look at lymph nodes and other areas inside the chest. Propofol is a sedative medicine used to help participants stay comfortable during the procedure.

Before EBUS, all participants will receive the usual information about the procedure as part of routine care. After this routine consent process, participants will answer short questions about what they understood. They will also answer questions about their anxiety before the procedure. The study will not change the usual consent process, sedation plan, or medical care.

During EBUS, participants will receive usual sedation and monitoring according to routine clinical practice. The research team will record how much sedative medicine is used, whether extra sedation is needed, whether any important clinical events occur, and how participants recover after sedation. The main question is whether participants who understand the consent information better need less propofol during EBUS.

研究概览

地位

招聘中

条件

详细说明

Endobronchial ultrasound (EBUS) is a minimally invasive bronchoscopic procedure commonly used to evaluate mediastinal and hilar lymph nodes and other intrathoracic lesions. Because airway stimulation, coughing, and patient movement may occur during the procedure, sedation is commonly used to improve patient comfort and procedural tolerance.

This prospective observational study will evaluate the relationship between participants' understanding of the informed consent information and their sedative requirement during EBUS. All participants will undergo the routine clinical informed consent process before the procedure. After this process, their understanding of the procedure will be assessed using a structured consent understanding assessment form developed by the investigators. Preprocedural anxiety will also be evaluated using a validated anxiety scale.

The study will not assign participants to any intervention and will not modify routine clinical care. Sedation, monitoring, and procedural management will be performed according to usual clinical practice. The research team will record perioperative data related to sedative medication use, need for additional sedation, sedation-related clinical events, and early recovery after the procedure. The planned analysis will assess whether a higher level of consent understanding is associated with lower propofol requirement during EBUS, while considering relevant clinical factors.

研究类型

观察性的

注册 (估计的)

75

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。

学习联系方式

研究联系人备份

学习地点

  • 土耳其（türkiye）
    • Bursa
      • Bursa、Bursa、土耳其（türkiye）、16059
        • 招聘中
        • Bursa Uludag University Faculty of Medicine Hospital
        • 接触：

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

不

取样方法

非概率样本

研究人群

Adult participants scheduled for elective endobronchial ultrasound under routine clinical sedation at Bursa Uludag University Faculty of Medicine Hospital. Eligible participants will be those who meet the study inclusion criteria and provide written informed consent for study participation.

描述

Inclusion Criteria:

  • Age 18 years or older
  • Scheduled for elective endobronchial ultrasound
  • ASA physical status I to III
  • Ability to read and understand Turkish
  • Provision of written informed consent for study participation

Exclusion Criteria:

  • Active psychiatric disease that may affect the informed consent process, anxiety assessment, or communication
  • Cognitive impairment, including dementia or delirium
  • Contraindication or known allergy to propofol, midazolam, or remifentanil
  • Emergency EBUS procedure
  • Regular anxiolytic or sedative drug use within the last month
  • Illiteracy
  • Turkish language barrier
  • Advanced organ failure or decompensated systemic disease that may significantly affect sedative drug response, hemodynamic stability, communication, or consent assessment

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

队列和干预

团体/队列
Adults Undergoing Elective Endobronchial Ultrasound
Adult participants scheduled for elective endobronchial ultrasound under routine clinical sedation. Participants will complete a structured assessment of consent understanding and a preprocedural anxiety assessment before the procedure. Sedative medication use, need for additional sedation, relevant clinical events, and early recovery after sedation will be recorded according to the study protocol.

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
Association Between Preoperative Consent Understanding Score and Intraoperative Propofol Consumption
大体时间：From initiation of propofol administration for EBUS sedation until completion of the EBUS procedure
The association between the Pre-EBUS Consent Understanding Teach-Back Scale score and intraoperative propofol consumption will be evaluated. The Pre-EBUS Consent Understanding Teach-Back Scale is an investigator-developed scale administered after signing the informed consent form and before the EBUS procedure. It consists of 10 items, each scored from 0 to 2, yielding a total score ranging from 0 to 20. Higher scores indicate better understanding of the procedure, sedation, potential risks, and post-procedural precautions. Propofol consumption will be calculated as the total propofol dose adjusted for body weight and procedure duration and expressed as mg/kg/hour.
From initiation of propofol administration for EBUS sedation until completion of the EBUS procedure

次要结果测量

结果测量
措施说明
大体时间
Association Between Consent Understanding Score and Preoperative Anxiety Score
大体时间：On the day of the procedure, before initiation of EBUS sedation
Preoperative anxiety will be assessed using the anxiety subscale of the Amsterdam Preoperative Anxiety and Information Scale. The anxiety subscale consists of four items scored from 1 to 5, yielding a total score ranging from 4 to 20. Higher scores indicate higher preoperative anxiety. The Pre-EBUS Consent Understanding Teach-Back Scale consists of 10 items, each scored from 0 to 2, yielding a total score ranging from 0 to 20, with higher scores indicating better understanding. The association between the Pre-EBUS Consent Understanding Teach-Back Scale score and the Amsterdam Preoperative Anxiety and Information Scale anxiety subscale score will be evaluated.
On the day of the procedure, before initiation of EBUS sedation
Additional Propofol Requirement During EBUS
大体时间：During the EBUS procedure
The need for additional propofol administration or an increase in propofol infusion during EBUS will be recorded according to clinical requirements.
During the EBUS procedure
Intraoperative Remifentanil Consumption
大体时间：During the EBUS procedure
Total remifentanil consumption during the procedure will be recorded and expressed as mcg/kg/hour.
During the EBUS procedure
Bispectral Index Course During Sedation
大体时间：During the EBUS procedure
Bispectral index values will be recorded during sedation to evaluate the course of sedation depth.
During the EBUS procedure
Early Recovery Characteristics After Sedation
大体时间：At 15 minutes after completion of the EBUS procedure
Early recovery after EBUS sedation will be assessed using the Modified Aldrete Score. The Modified Aldrete Score evaluates activity, respiration, circulation, consciousness, and oxygen saturation. Each component is scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate better post-sedation recovery.
At 15 minutes after completion of the EBUS procedure
Patient Satisfaction After Sedation
大体时间：At 30 minutes after completion of the EBUS procedure
Patient satisfaction after EBUS sedation will be assessed using a 5-point Likert-type satisfaction scale. The score ranges from 1 to 5, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater patient satisfaction.
At 30 minutes after completion of the EBUS procedure

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。

赞助

Uludag University

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。

一般刊物

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)

2026年7月10日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月1日

研究记录更新

最后更新发布 (实际的)

2026年8月25日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BUU-EBUS-CUP-2026-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared because participants did not provide specific consent for public or external individual-level data sharing. The study data will be coded and used only for the purposes of this research. Aggregate results may be reported in scientific publications.

药物和器械信息、研究文件

研究美国 FDA 监管的设备产品

不

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.

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