Consent Understanding and Propofol Requirement During Endobronchial Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Procedural Sedation and Analgesia, Informed Consent. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association of Preoperative Consent Understanding With Propofol Requirement During Endobronchial Ultrasound: A Prospective Observational Study
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- Association Between Consent Understanding Score and Preoperative Anxiety Score [Time frame: On the day of the procedure, before initiation of EBUS sedation]
- Additional Propofol Requirement During EBUS [Time frame: During the EBUS procedure]
- Intraoperative Remifentanil Consumption [Time frame: During the EBUS procedure]
- Bispectral Index Course During Sedation [Time frame: During the EBUS procedure]
- Early Recovery Characteristics After Sedation [Time frame: At 15 minutes after completion of the EBUS procedure]
- Patient Satisfaction After Sedation [Time frame: At 30 minutes after completion of the EBUS procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Bursa Uludag University Faculty of Medicine Hospital — Bursa
Publications
- 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
- 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
- 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
- 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: 10.116 PMID 25574801
- 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
- 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
Identifiers
NCT: NCT07677982 · BUU-EBUS-CUP-2026-01