General Anesthesia vs Conscious Sedation for Radial Endobronchial Ultrasound
A Randomized Controlled Trial of gEneral aneStheSia vs consciOUs Sedation in Radial endobronChial Ultrasound for Peripheral Pulmonary lEsions
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
306 participants
Sep 25, 2025
INTERVENTIONAL
Conditions
Summary
The endoscopic investigation of lung lesions is experiencing significant growth with the increasing number of lung cancer screening programs. Peripheral endobronchial ultrasound (pEBUS) is the most widely used endoscopic technique in the investigation of peripheral pulmonary lesions (PPL). It is performed in relatively equal proportions under conscious sedation and general anesthesia by interventional pulmonologists throughout the world. Users of conscious sedation justify themselves by the fewer resources consumed and the absence of demonstration of a superior diagnostic yield of general anesthesia while users of general anesthesia claim diagnostic yield and comfort for the patient are superior with their approach. Our main objective is to compare the diagnostic yield of pEBUS under general anesthesia to that obtained under conscious sedation.
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Interventions
In the conscious sedation group, the procedure will be performed through the nose or mouth at the discretion of the endoscopist. The patient will remain breathing spontaneously throughout the procedure and will be administered oxygen through a nasal cannula at an initial flow rate of 2L/min. A combination of propofol, fentanyl and midazolam boluses will be used to maintain moderate sedation. At IUCPQ-UL, fentanyl and midazolam will be used as in our routine practice. The boluses will be prescribed by a doctor experienced in conscious sedation (anesthesiologist, intensivist or pulmonologist) according to the patient's state of wakefulness assessed by the Richmond Agitation-Sedation Scale (RAS) .Centers will decide, prior to initiating recruitment locally, the drug combination used to sedate patients and they will maintain the use of the same drug combination throughout the study
In the general anesthesia group, an endotracheal tube larger than 7 will be used. The patient will be kept non-arousable to non-nociceptive stimulation (RAS = -5) by a perfusion including, at the anesthesiologist's discretion: fentanyl, sufentanyl, remifentanyl, midazolam or propofol. The sedation of this group will not be protocolized given the wide variety of practices in the participating centers, but the targeted level of sedation will be and the medication administered will be adjusted according to this target. The RAS will be evaluated every 5 minutes, or earlier if signs of arousal are present, to ensure that the intended target is maintained and adjustments to the rate of infusions as well as boluses may be made/administered by the anesthesiologist to maintain the targeted level of sedation. Patients may be paralyzed at the discretion of the anesthesiologit. The ventilatory parameters will be standardized according to the VESPA protocol
Locations(1)
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NCT06950515