ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATIONProcedural Sedation and AnalgesiaInformed Consent
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Association Between Preoperative Consent Understanding Score and Intraoperative Propofol Consumption — 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.
Trial sites (1)
Facility
City
Region
Status
Bursa Uludag University Faculty of Medicine Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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