ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Informed Consent, Procedural Sedation and Analgesia
Conditions
Keywords
EBUS-TBNA, Informed consent understanding, Procedural sedation, Preoperative anxiety, Sedative requirement, Propofol consumption
Brief 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.
Detailed description
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.
Interventions
None listed
Sponsors
Uludag University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Consent Understanding Score and Preoperative Anxiety Score | On the day of the procedure, before initiation of EBUS sedation | 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. |
| Patient Satisfaction After Sedation | At 30 minutes after completion of the EBUS procedure | 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. |
| Intraoperative Remifentanil Consumption | During the EBUS procedure | Total remifentanil consumption during the procedure will be recorded and expressed as mcg/kg/hour. |
| Bispectral Index Course During Sedation | During the EBUS procedure | Bispectral index values will be recorded during sedation to evaluate the course of sedation depth. |
| Early Recovery Characteristics After Sedation | At 15 minutes after completion of the EBUS procedure | 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. |
| Additional Propofol Requirement During EBUS | During the EBUS procedure | The need for additional propofol administration or an increase in propofol infusion during EBUS will be recorded according to clinical requirements. |
Countries
Turkey (Türkiye)
Contacts
CONTACTGokce Kizilkale Kayikci, MD
CONTACTLeman Gokcenur Aydin, MD
Outcome results
None listed