Hemodynamic StabilityNCT07338578
A Study Comparing Sevoflurane and Propofol in Patients Undergoing Endobronchial Ultrasound Guided Needle Aspiration
An observational study of Hemodynamic Stability and Pulmonary Diseases or Conditions, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Stability, Pulmonary Diseases or Conditions, Complication of Anesthesia
- What is being tested?
- propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 5 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adults (> 18 years) with an ASA physical status I-III who provided written informed consent were included.
Who cannot join
- ASA ≥ IV
- chronic cough or dyspnea
- preoperative desaturation (SpO₂ < 90%)
- hypotension (MAP < 60 mmHg),
- bradycardia (HR < 60 bpm),
- hypersensitivity to anesthetics,
Show all 9Show fewer
- any form of organ failure,
- laboratory abnormalities (electrolyte imbalance, anemia, polycythemia, thrombocytosis, leukopenia, or leukocytosis),
- perioperative hypo- or hyperthermia, dehydration, or overhydration.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Uskudar, 34668
About this study
Official title: Comparison of Propofol and Sevoflurane in Terms of Hemodynamics and Bronchoscopist Satisfaction in Patients Who Underwent Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Under General Anesthesia
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.
Read the detailed description
This prospective, single-center, observational cohort study was designed to compare the effects of two general anesthesia techniques-propofol based total intravenous anesthesia (TIVA) and sevoflurane based inhalational anesthesia-on hemodynamic parameters and bronchoscopist satisfaction in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).
EBUS-TBNA is a minimally invasive bronchoscopic procedure that allows tissue sampling from mediastinal and hilar lymph nodes or pulmonary nodules. The procedure plays a major role in the diagnosis and staging of lung cancer and other mediastinal pathologies. Although EBUS-TBNA has become an established diagnostic tool with a high safety profile, anesthetic management during the procedure remains a matter of debate. Appropriate anesthesia choice affects not only patient safety and comfort but also the bronchoscopist's technical performance.
Patients scheduled for EBUS-TBNA under general anesthesia were included after obtaining institutional ethics approval. Individuals aged 18 years or older with American Society of Anesthesiologists (ASA) physical status I-III were eligible. Exclusion criteria included incomplete medical records, combined surgical interventions, severe hemodynamic instability, or ASA class IV or higher. All patients provided written informed consent prior to the procedure.
The study population was divided into two groups according to the anesthetic technique used. In the Sevoflurane Group, anesthesia was induced with intravenous agents and maintained using inhalational sevoflurane in a mixture of oxygen and air. In the Propofol Group, anesthesia was maintained with continuous intravenous infusion of propofol. In both groups, anesthesia depth was monitored clinically and adjusted to maintain stable hemodynamics and adequate oxygenation. All procedures were performed with the patient in the supine position under controlled ventilation using a size 4 laryngeal mask airway (LMA), chosen for its ability to maintain a secure airway and allow sufficient space for bronchoscopic manipulation.
Standard monitoring included continuous electrocardiography, noninvasive blood pressure measurement, pulse oximetry, and capnography. Hemodynamic parameters such as heart rate, mean arterial pressure (MAP), oxygen saturation (SpO₂), and end-tidal CO₂ (EtCO₂) were recorded at baseline (pre-induction), after induction, during bronchoscope insertion, at 5-minute intervals during the procedure, and immediately after completion. The total doses of anesthetic and vasoactive drugs, as well as the need for supplemental medications, were documented.
At the end of the procedure the occurrence of complications such as hypoxia, bronchospasm, coughing, or airway trauma were also noted. The bronchoscopist, blinded to the anesthetic regimen, evaluated procedural satisfaction immediately after each case using a standardized satisfaction scale (graded as poor, fair, good, or excellent). Factors considered included surgical field stability, visibility, and patient movement.
The primary outcome measure of the study was hemodynamic stability, assessed through changes in mean arterial pressure and heart rate between groups. Secondary outcome measures included bronchoscopist satisfaction, airway related complications. Descriptive statistics were used for demographic and procedural variables. Intergroup comparisons were performed using Student's t-test or Mann-Whitney U test for continuous variables and chi-square or Fisher's exact test for categorical variables. A p-value < 0.05 was considered statistically significant.
The results of this study are expected to provide evidence regarding the relative advantages and limitations of propofol and sevoflurane anesthesia in EBUS-TBNA procedures. Understanding how each anesthetic technique affects intraoperative stability and procedural comfort can help optimize anesthetic management strategies, improve patient safety, and enhance bronchoscopist performance in minimally invasive airway interventions.
- Being tested
- propofol, Sevoflurane
- Keywords
- EBUS, Propofol, Sevoflurane, Outpatient Anesthesia, General Anesthesia
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Diprivan
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.
SevofluraneDrug
Also called Sevorane
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Propofol Group | Group 1: Patients who received total intravenous anesthesia (TIVA) with propofol during EBUS-TBNA. Receives: Drug: propofol | |
| Group 2: Sevoflurane Group | Patients who received inhalational anesthesia with sevoflurane during EBUS-TBNA. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after completion of the procedure.
Secondary outcomes (1)
Procedure-Related Complications
To record and compare the incidence of complications such as hypoxia, bronchospasm, cough, laryngospasm, airway trauma, and postoperative nausea or vomiting between the two anesthesia techniques.
Measured: During the procedure and up to 1 hour postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Sep 2023
- Primary completion4 Mar 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic StabilityStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Burcu Sari, MD, Principal investigator, University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research HospitalTuna Erturk, MD, Study chair, University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research HospitalSuheyla Abitagaoglu, MD, Study chair, University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338578
- Sponsor's protocol ID
- SBU-HAMIDIYE-23-57
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol and Sevoflurane in Terms of Hemodynamics and Bronchoscopist Satisfaction in Patients Who Underwent Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07338578
- Acronym / sponsor ID
- SBU-HAMIDIYE-23-57
- Keywords
- EBUS, Propofol, Sevoflurane, Outpatient Anesthesia, General Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, single-center, observational cohort study was designed to compare the effects of two general anesthesia techniques-propofol based total intravenous anesthesia (TIVA) and sevoflurane based inhalational anesthesia-on hemodynamic parameters and bronchoscopist satisfaction in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).
EBUS-TBNA is a minimally invasive bronchoscopic procedure that allows tissue sampling from mediastinal and hilar lymph nodes or pulmonary nodules. The procedure plays a major role in the diagnosis and staging of lung cancer and other mediastinal pathologies. Although EBUS-TBNA has become an established diagnostic tool with a high safety profile, anesthetic management during the procedure remains a matter of debate. Appropriate anesthesia choice affects not only patient safety and comfort but also the bronchoscopist's technical performance.
Patients scheduled for EBUS-TBNA under general anesthesia were included after obtaining institutional ethics approval. Individuals aged 18 years or older with American Society of Anesthesiologists (ASA) physical status I-III were eligible. Exclusion criteria included incomplete medical records, combined surgical interventions, severe hemodynamic instability, or ASA class IV or higher. All patients provided written informed consent prior to the procedure.
The study population was divided into two groups according to the anesthetic technique used. In the Sevoflurane Group, anesthesia was induced with intravenous agents and maintained using inhalational sevoflurane in a mixture of oxygen and air. In the Propofol Group, anesthesia was maintained with continuous intravenous infusion of propofol. In both groups, anesthesia depth was monitored clinically and adjusted to maintain stable hemodynamics and adequate oxygenation. All procedures were performed with the patient in the supine position under controlled ventilation using a size 4 laryngeal mask airway (LMA), chosen for its ability to maintain a secure airway and allow sufficient space for bronchoscopic manipulation.
Standard monitoring included continuous electrocardiography, noninvasive blood pressure measurement, pulse oximetry, and capnography. Hemodynamic parameters such as heart rate, mean arterial pressure (MAP), oxygen saturation (SpO₂), and end-tidal CO₂ (EtCO₂) were recorded at baseline (pre-induction), after induction, during bronchoscope insertion, at 5-minute intervals during the procedure, and immediately after completion. The total doses of anesthetic and vasoactive drugs, as well as the need for supplemental medications, were documented.
At the end of the procedure the occurrence of complications such as hypoxia, bronchospasm, coughing, or airway trauma were also noted. The bronchoscopist, blinded to the anesthetic regimen, evaluated procedural satisfaction immediately after each case using a standardized satisfaction scale (graded as poor, fair, good, or excellent). Factors considered included surgical field stability, visibility, and patient movement.
The primary outcome measure of the study was hemodynamic stability, assessed through changes in mean arterial pressure and heart rate between groups. Secondary outcome measures included bronchoscopist satisfaction, airway related complications. Descriptive statistics were used for demographic and procedural variables. Intergroup comparisons were performed using Student's t-test or Mann-Whitney U test for continuous variables and chi-square or Fisher's exact test for categorical variables. A p-value < 0.05 was considered statistically significant.
The results of this study are expected to provide evidence regarding the relative advantages and limitations of propofol and sevoflurane anesthesia in EBUS-TBNA procedures. Understanding how each anesthetic technique affects intraoperative stability and procedural comfort can help optimize anesthetic management strategies, improve patient safety, and enhance bronchoscopist performance in minimally invasive airway interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Propofol Group | – | Drug: propofolGroup 1: Patients who received total intravenous anesthesia (TIVA) with propofol during EBUS-TBNA. |
| Group 2: Sevoflurane Group | – | Drug: SevofluranePatients who received inhalational anesthesia with sevoflurane during EBUS-TBNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adults (> 18 years) with an ASA physical status I-III who provided written informed consent were included.
Key exclusion criteria (9 listed)
- ASA ≥ IV
- chronic cough or dyspnea
- preoperative desaturation (SpO₂ < 90%)
- hypotension (MAP < 60 mmHg),
- bradycardia (HR < 60 bpm),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: DiprivanIn 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. | Drug | Group 1: Propofol Group |
| SevofluraneAlso: SevoraneIn 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. | Drug | Group 2: Sevoflurane Group |
Primary outcome
Change in Systolic Blood Pressure During EBUS-TBNA
Time frame: Periprocedural period (from anesthesia induction to 60 minutes after procedure completion)
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.
Change in Diastolic Blood Pressure During EBUS-TBNA
Time frame: Periprocedural period (from anesthesia induction to 60 minutes after procedure completion)
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.
Change in Heart Rate During EBUS-TBNA
Time frame: Periprocedural period (from anesthesia induction to 60 minutes after procedure completion)
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.
Bronchoscopist Satisfaction Score During EBUS-TBNA
Time frame: Immediately after completion of the procedure.
Bronchoscopist satisfaction will be assessed using a standardized 5-point Likert scale, where higher scores indicate greater satisfaction.
1 secondary outcome
Procedure-Related Complications
Time frame: During the procedure and up to 1 hour postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu Sari, MD principal investigator
University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
Tuna Erturk, MD study chair
University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
Suheyla Abitagaoglu, MD study chair
University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Stability and Pulmonary Diseases or Conditions, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure During EBUS-TBNA (time frame: Periprocedural period (from anesthesia induction to 60 minutes after procedure completion)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.