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NCT Number: NCT07677982

Consent Understanding and Propofol Requirement During Endobronchial Ultrasound

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.

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Key information

Conditions

ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION Agnosia Informed Consent Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Procedural Sedation and Analgesia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Uludag University Faculty of Medicine Hospital

Bursa, 16059, Turkey (Türkiye)

Location contact

Gökçe Kızılkale Kayıkcı, MD

CONTACT

[email protected]

+90 533 735 6397

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Association Between Preoperative Consent Understanding Score and Intraoperative Propofol Consumption

    Time frame: 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 outcomes

  1. Association Between Consent Understanding Score and Preoperative Anxiety Score

    Time frame: 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.

  2. Additional Propofol Requirement During EBUS

    Time frame: 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.

  3. Intraoperative Remifentanil Consumption

    Time frame: During the EBUS procedure

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

  4. Bispectral Index Course During Sedation

    Time frame: During the EBUS procedure

    Bispectral index values will be recorded during sedation to evaluate the course of sedation depth.

  5. Early Recovery Characteristics After Sedation

    Time frame: 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.

  6. Patient Satisfaction After Sedation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gokce Kizilkale Kayikci, MD

CONTACT

[email protected]

+90 533 735 63 97

Leman Gokcenur Aydin, MD

CONTACT

[email protected]

+90 224 295 32 76

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

Association of Preoperative Consent Understanding With Propofol Requirement During Endobronchial Ultrasound: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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