NCT07338578

Brief Summary

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure used to obtain samples from mediastinal and hilar lymph nodes or lung parenchymal lesions for diagnostic and staging purposes. The success and safety of the procedure, including diagnostic yield, complication rates, and bronchoscopist comfort, depend largely on the choice of anesthesia technique. General anesthesia is frequently preferred because it provides a stable airway, adequate ventilation, and improved procedural conditions. Patient-related factors such as medical status, history, procedure duration, and number of needle passes may influence hemodynamic stability and tolerance, making anesthesiologist involvement essential. Previous studies comparing intravenous and inhalational anesthesia in various surgical and bronchoscopic procedures have evaluated their effects on hemodynamics, complications, recovery time, visibility of the surgical field, and postoperative outcomes. However, there is limited evidence directly comparing propofol-based total intravenous anesthesia and sevoflurane-based inhalational anesthesia specifically for EBUS-TBNA. This study aims to compare the effects of propofol and sevoflurane anesthesia on perioperative hemodynamic parameters, respiratory stability, and procedure-related complications in patients undergoing EBUS-TBNA. In addition, the study assesses bronchoscopist satisfaction with each anesthetic technique, including procedural comfort and working conditions. The findings are expected to contribute to optimizing anesthetic management for EBUS-TBNA, improving patient safety, and enhancing procedural quality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 17, 2025

Last Update Submit

January 3, 2026

Conditions

Keywords

EBUSPropofolSevofluraneOutpatient AnesthesiaGeneral Anesthesia

Outcome Measures

Primary Outcomes (4)

  • Change in Systolic Blood Pressure During EBUS-TBNA

    Systolic blood pressure (mmHg) will be measured at baseline (pre-induction), immediately after induction, during the procedure at 5-minute intervals, at the end of the procedure, and upon arrival in the recovery room. Values will be compared between the propofol and sevoflurane groups.

    Periprocedural period (from anesthesia induction to 60 minutes after procedure completion)

  • Change in Diastolic Blood Pressure During EBUS-TBNA

    Diastolic blood pressure (mmHg) will be measured at baseline (pre-induction), immediately after induction, during the procedure at 5-minute intervals, at the end of the procedure, and upon arrival in the recovery room. Values will be compared between the propofol and sevoflurane groups.

    Periprocedural period (from anesthesia induction to 60 minutes after procedure completion)

  • Change in Heart Rate During EBUS-TBNA

    Heart rate (beats per minute) will be recorded at baseline (pre-induction), immediately after induction, during the procedure at 5-minute intervals, at the end of the procedure, and upon arrival in the recovery room. Values will be compared between the propofol and sevoflurane groups.

    Periprocedural period (from anesthesia induction to 60 minutes after procedure completion)

  • Bronchoscopist Satisfaction Score During EBUS-TBNA

    Bronchoscopist satisfaction will be assessed using a standardized 5-point Likert scale, where higher scores indicate greater satisfaction.

    Immediately after completion of the procedure.

Secondary Outcomes (1)

  • Procedure-Related Complications

    During the procedure and up to 1 hour postoperatively.

Study Arms (2)

Group 1: Propofol Group

Group 1: Patients who received total intravenous anesthesia (TIVA) with propofol during EBUS-TBNA.

Drug: propofol

Group 2: Sevoflurane Group

Patients who received inhalational anesthesia with sevoflurane during EBUS-TBNA.

Drug: Sevoflurane

Interventions

In group 1, anesthesia was induced intravenously and maintained using propofol to achieve an adequate depth of anesthesia and hemodynamic stability during EBUS- TBNA. The airway was managed with a size 4 laryngeal mask airway (LMA) allowing bronchoscope insertion and controlled ventilation. Standard monitoring included ECG, noninvasive blood pressure, pulse oximetry, and capnography.

Also known as: Diprivan
Group 1: Propofol Group

In group 2, following intravenous induction, anesthesia was maintained using sevoflurane in an oxygen-air mixture to ensure adequate depth of anesthesia and hemodynamic stability during EBUS-TBNA. Airway management was achieved using a size 4 laryngeal mask airway (LMA) to facilitate bronchoscope insertion and controlled ventilation. Standard monitoring included ECG, noninvasive blood pressure, pulse oximetry, and capnography.

Also known as: Sevorane
Group 2: Sevoflurane Group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consisted of adult patients who underwent endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) under general anesthesia at a tertiary training and research hospital. All participants were scheduled for diagnostic bronchoscopy for evaluation of pulmonary or mediastinal lesions. Patients with American Society of Anesthesiologists (ASA) physical status I-III were included.

You may qualify if:

  • Adults (\> 18 years) with an ASA physical status I-III who provided written informed consent were included.

You may not qualify if:

  • ASA ≥ IV
  • chronic cough or dyspnea
  • preoperative desaturation (SpO₂ \< 90%)
  • hypotension (MAP \< 60 mmHg),
  • bradycardia (HR \< 60 bpm),
  • hypersensitivity to anesthetics,
  • any form of organ failure,
  • laboratory abnormalities (electrolyte imbalance, anemia, polycythemia, thrombocytosis, leukopenia, or leukocytosis),
  • perioperative hypo- or hyperthermia, dehydration, or overhydration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Burcu Sari, MD

    University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Tuna Erturk, MD

    University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital

    STUDY CHAIR
  • Suheyla Abitagaoglu, MD

    University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

January 14, 2026

Study Start

September 1, 2023

Primary Completion

March 4, 2024

Study Completion

April 5, 2024

Last Updated

January 14, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The data include patient-specific clinical information collected under institutional ethics approval and are intended for internal research analysis only. Summary results may be shared in scientific publications and presentations.

Locations