Consent Understanding and Propofol Requirement During Endobronchial Ultrasound

NCT07677982 | Not Yet Recruiting

• 1 other identifier: BUU-EBUS-CUP-2026-01
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION; Procedural Sedation and Analgesia; Informed Consent

Keywords

EBUS-TBNA; Informed consent understanding; Procedural sedation; Preoperative anxiety; Sedative requirement; Propofol consumption

Outcome Measures

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.

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

Secondary Outcomes (6)

• Association Between Consent Understanding Score and Preoperative Anxiety Score

  On the day of the procedure, before initiation of EBUS sedation

• Additional Propofol Requirement During EBUS

  During the EBUS procedure

• Intraoperative Remifentanil Consumption

  During the EBUS procedure

• Bispectral Index Course During Sedation

  During the EBUS procedure

• Early Recovery Characteristics After Sedation

  At 15 minutes after completion of the EBUS procedure

Study Arms (1)

Adults Undergoing Elective Endobronchial Ultrasound

Adult participants scheduled for elective endobronchial ultrasound under routine clinical sedation. Participants will complete a structured assessment of consent understanding and a preprocedural anxiety assessment before the procedure. Sedative medication use, need for additional sedation, relevant clinical events, and early recovery after sedation will be recorded according to the study protocol.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University Faculty of Medicine Hospital

Bursa, Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (6)

• Cetinkaya F, Kavuran E, Unal Aslan KS. Validity and reliability of the Amsterdam Preoperative Anxiety and Information Scale in the Turkish population. Turk J Med Sci. 2019 Feb 11;49(1):178-183. doi: 10.3906/sag-1806-84.

  PMID: 30764595 BACKGROUND

• Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.

  PMID: 8623940 BACKGROUND

• Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009 Sep;198(3):420-35. doi: 10.1016/j.amjsurg.2009.02.010.

  PMID: 19716887 BACKGROUND

• Casal RF, Lazarus DR, Kuhl K, Nogueras-Gonzalez G, Perusich S, Green LK, Ost DE, Sarkiss M, Jimenez CA, Eapen GA, Morice RC, Cornwell L, Austria S, Sharafkanneh A, Rumbaut RE, Grosu H, Kheradmand F. Randomized trial of endobronchial ultrasound-guided transbronchial needle aspiration under general anesthesia versus moderate sedation. Am J Respir Crit Care Med. 2015 Apr 1;191(7):796-803. doi: 10.1164/rccm.201409-1615OC.

  PMID: 25574801 BACKGROUND

• Grendelmeier P, Kurer G, Pflimlin E, Tamm M, Stolz D. Feasibility and safety of propofol sedation in flexible bronchoscopy. Swiss Med Wkly. 2011 Aug 26;141:w13248. doi: 10.4414/smw.2011.13248. eCollection 2011.

  PMID: 21870301 BACKGROUND

• Wahidi MM, Herth F, Yasufuku K, Shepherd RW, Yarmus L, Chawla M, Lamb C, Casey KR, Patel S, Silvestri GA, Feller-Kopman DJ. Technical Aspects of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: CHEST Guideline and Expert Panel Report. Chest. 2016 Mar;149(3):816-35. doi: 10.1378/chest.15-1216. Epub 2016 Jan 12.

  PMID: 26402427 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gokce Kizilkale Kayikci, MD

CONTACT

+90 533 735 63 97; gkizilkale@uludag.edu.tr

Leman Gokcenur Aydin, MD

CONTACT

+90 224 295 32 76; lgaydin@uludag.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)