A Study Comparing Sevoflurane and Propofol in Patients Undergoing Endobronchial Ultrasound Guided Needle Aspiration

NCT ID: NCT07338578

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-04-05

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.

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.

Conditions

Hemodynamic Stability; Pulmonary Diseases or Conditions; Complication of Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: Propofol Group

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

propofol

Intervention Type: DRUG

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.

Group 2: Sevoflurane Group

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

Sevoflurane

Intervention Type: DRUG

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.

Interventions

propofol

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.

Intervention Type: DRUG

Sevoflurane

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.

Intervention Type: DRUG

Other Intervention Names

Diprivan; Sevorane

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Burcu Sari, MD

Role: PRINCIPAL_INVESTIGATOR

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

Tuna Erturk, MD

Role: STUDY_CHAIR

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

Suheyla Abitagaoglu, MD

Role: STUDY_CHAIR

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

Locations

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

Istanbul, Uskudar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SBU-HAMIDIYE-23-57

Identifier Type: -

Identifier Source: org_study_id