Consent Understanding and Propofol Requirement During Endobronchial Ultrasound

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUludag University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

75 Participants
are grouped into 1 trial group
Group A: Adults Undergoing Elective Endobronchial Ultrasound

Trial outcomes

Primary outcomes

1

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.

Time frame
From initiation of propofol administration for EBUS sedation until completion of the EBUS procedure

Secondary outcomes

1

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
2

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
3

Intraoperative Remifentanil Consumption

Total remifentanil consumption during the procedure will be recorded and expressed as mcg/kg/hour.

Time frame
During the EBUS procedure
4

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

Other outcomes

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