Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Consent Understanding and Propofol Requirement During Endobronchial Ultrasound

24. august 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

75

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
    • Bursa
      • Bursa, Bursa, Tyrkia (Türkiye), 16059
        • Rekruttering
        • Bursa Uludag University Faculty of Medicine Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Association Between Preoperative Consent Understanding Score and Intraoperative Propofol Consumption
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Association Between Consent Understanding Score and Preoperative Anxiety Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Uludag University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. juli 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

30. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BUU-EBUS-CUP-2026-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere