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.
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.
Study Type
OBSERVATIONAL
Enrollment
75
Bursa Uludag University Faculty of Medicine Hospital
Bursa, Bursa, Turkey (Türkiye)
RECRUITINGAssociation 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.
Time frame: From initiation of propofol administration for EBUS sedation until completion of the EBUS procedure
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.
Time frame: On the day of the procedure, before initiation of EBUS sedation
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.
Time frame: During the EBUS procedure
Intraoperative Remifentanil Consumption
Total remifentanil consumption during the procedure will be recorded and expressed as mcg/kg/hour.
Time frame: During the EBUS procedure
Bispectral Index Course During Sedation
Bispectral index values will be recorded during sedation to evaluate the course of sedation depth.
Time frame: During the EBUS procedure
Early Recovery Characteristics After Sedation
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.
Time frame: At 15 minutes after completion of the EBUS procedure
Patient Satisfaction After Sedation
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.
Time frame: At 30 minutes after completion of the EBUS procedure
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