Consent Understanding and Propofol Use During EBUS
Official title: Association of Preoperative Consent Understanding With Propofol Requirement During Endobronchial Ultrasound: A Prospective Observational Study
Run by Uludag University · NCT07677982 · Data updated 2026-11-12
This observational study will see if how well patients understand their consent affects the amount of propofol needed during endobronchial ultrasound (EBUS).
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Uludag University Academic / other |
| Locations | 1 site (Bursa, Bursa) |
| Status | Recruiting |
| Started | July 10, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT07677982 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older scheduled for elective EBUS, able to read and understand Turkish, and providing informed consent for the study.
✕Probably not a fit
Patients who do not fully understand the consent assessment or who have high baseline anxiety due to factors unrelated to consent may not experience a reduction in sedative needs.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study examines whether a patient’s grasp of informed consent relates to the dose of propofol required during EBUS-TBNA. All participants receive the standard pre-procedure consent and then complete a consent understanding assessment and an anxiety scale before the procedure. Sedation and monitoring follow usual clinical practice, and data on sedative use, additional sedation needs, and early recovery are collected. The analysis will adjust for clinical factors to see if better consent understanding associates with lower propofol requirements. No interventions or changes to standard care are made during the study.
Why it matters
Potential benefit: If the association is found, it could support targeted consent discussions or anxiety-reduction strategies to optimize sedation needs during EBUS.
How similar studies have gone: Prior observational work in procedural sedation has explored factors affecting sedative requirements, but this specific link between consent understanding and propofol dose in EBUS is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Bursa Uludag University Faculty of Medicine Hospital
Bursa, Bursa, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Gokce Kizilkale Kayikci, MD
- Email: gkizilkale@uludag.edu.tr
- Phone: +90 533 735 63 97
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.