Consent Understanding and Propofol Requirement During Endobronchial Ultrasound
Recruiting · NCT07677982 · Observational (researchers observe without assigning treatment) · Lead sponsor: Uludag University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Bursa Uludag University Faculty of Medicine Hospital - Bursa, Bursa, Turkey (Türkiye)