跳至主要内容
临床试验/NCT07338578
NCT07338578已完成不适用

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

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Change in Systolic Blood Pressure During EBUS-TBNA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Group 1: Propofol Group

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

干预措施: propofol (Drug)

Group 2: Sevoflurane Group

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

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Change in Systolic Blood Pressure During EBUS-TBNA

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Immediately after completion of the procedure.

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

次要结局

  • Procedure-Related Complications(During the procedure and up to 1 hour postoperatively.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

A Study Comparing Sevoflurane and Propofol in... | 临床试验