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Consent Understanding and Propofol Requirement During Endobronchial Ultrasound

24 augusti 2026 uppdaterad av: Gökçe Kızılkale Kayıkcı, Uludag University

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

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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

75

Kontakter och platser

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Studiekontakt

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Studieorter

  • Turkiet (Türkiye)
    • Bursa
      • Bursa, Bursa, Turkiet (Türkiye), 16059
        • Rekrytering
        • Bursa Uludag University Faculty of Medicine Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Association Between Preoperative Consent Understanding Score and Intraoperative Propofol Consumption
Tidsram: 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.
From initiation of propofol administration for EBUS sedation until completion of the EBUS procedure

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Association Between Consent Understanding Score and Preoperative Anxiety Score
Tidsram: 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.
On the day of the procedure, before initiation of EBUS sedation
Additional Propofol Requirement During EBUS
Tidsram: 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.
During the EBUS procedure
Intraoperative Remifentanil Consumption
Tidsram: During the EBUS procedure
Total remifentanil consumption during the procedure will be recorded and expressed as mcg/kg/hour.
During the EBUS procedure
Bispectral Index Course During Sedation
Tidsram: During the EBUS procedure
Bispectral index values will be recorded during sedation to evaluate the course of sedation depth.
During the EBUS procedure
Early Recovery Characteristics After Sedation
Tidsram: 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.
At 15 minutes after completion of the EBUS procedure
Patient Satisfaction After Sedation
Tidsram: 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.
At 30 minutes after completion of the EBUS procedure

Samarbetspartners och utredare

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Sponsor

Uludag University

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 juli 2026

Primärt slutförande (Beräknad)

1 juli 2027

Avslutad studie (Beräknad)

1 juli 2027

Studieregistreringsdatum

Först inskickad

23 juni 2026

Först inskickad som uppfyllde QC-kriterierna

30 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • BUU-EBUS-CUP-2026-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared because participants did not provide specific consent for public or external individual-level data sharing. The study data will be coded and used only for the purposes of this research. Aggregate results may be reported in scientific publications.

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