About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Scheduled for elective endobronchial ultrasound
ASA physical status I to III
Ability to read and understand Turkish
Disqualifiers
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
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Association Between Preoperative Consent Understanding Score and Intraoperative Propofol Consumption
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.
Secondary outcomes
Association Between Consent Understanding Score and Preoperative Anxiety Score
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.
Additional Propofol Requirement During EBUS
The need for additional propofol administration or an increase in propofol infusion during EBUS will be recorded according to clinical requirements.
Intraoperative Remifentanil Consumption
Total remifentanil consumption during the procedure will be recorded and expressed as mcg/kg/hour.
Bispectral Index Course During Sedation
Bispectral index values will be recorded during sedation to evaluate the course of sedation depth.
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