At a glance
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Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During US-guided Transbronchial Needle Aspiration (EBUS-TBNA): a Randomized, Prospective, Control Study
In Brief
A clinical study evaluating Remifentanil TCI, Midazolam injection, and 2 other interventions for Lung Cancer and 3 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Background: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure for diagnosing and staging mediastinal lymph node lesions in lung cancer. Adequate sedation is crucial for patient comfort and diagnostic accuracy. Different sedation modalities, including moderate sedation/conscious sedation, deep sedation, and general anesthesia, are utilized. This study aims to evaluate patient comfort and satisfaction levels of healthcare providers (bronchoscopists and anesthesiologists) when administering remifentanil through Target Controlled Infusion (TCI) for conscious sedation during EBUS-TBNA. A prospective randomized study design compares this approach to the standard sedation protocol involving midazolam, fentanyl, and/or propofol. Methods: this study will enroll 30 eligible patients randomly divided into two groups. Group 1, "REMIFENTANIL TCI", underwent EBUS-TBNA under conscious sedation with remifentanil TCI infusion targeting a concentration of 3-6 ng/ml. Group 2, "STANDARD", received conscious sedation with a combination of midazolam, fentanyl, and/or propofol administered in boluses based on clinical requirements. Complications, safety, and satisfaction levels of the operator, anesthesiologist, and patients will be evaluated.
Study Details
Timeline
Interventions
REMI-TCI administration begun 5 minutes before the procedure, starting from an initial target at the effect site of 1 ng/ml and gradually increasing by 0.5 ng/ml until reaching an adequate level of sedation (Ramsey score between 2-3).
Bolus administration of midazolam (1-2 mg)and/or until a Ramsey score 2-3 was reached
Bolus adminitration of fentanyl (50-100 mcg) until a Ramsey score 2-3 was reached
Bolus adminitration of propofol until a Ramsey score 2-3 was reached