Clinical trial · Interventional
Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During EBUS-TBNA
Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During US-guided Transbronchial Needle Aspiration (EBUS-TBNA): a Randomized, Prospective, Control Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endoscopy | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung; Node | — | UNRESOLVED | — |
| Sedation Complication | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl | Drug | — | UNRESOLVED |
| Midazolam injection | Drug | — | UNRESOLVED |
| Propofol | Drug | — | UNRESOLVED |
| Remifentanil TCI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 "REMIFENTANIL TCI" (Experimental Group)
- description
- the patients performed the EBUS-TBNA procedure under conscious sedation with infusion of Remifentanil TCI with a target between 3 and 6 ng/ml;
- interventionNames
- Drug: Remifentanil TCI
- type
- ACTIVE_COMPARATOR
- label
- Group 2 "STANDARD" (Control Group)
- description
- the patients performed the EBUS-TBNA procedure in conscious sedation with the association of midazolam and/or fentanyl and/or propofol in refracted boluses based on clinical needs (agitation, unsatisfactory level of sedation or not collaborative patient) and according to the anesthesiologist's clinical judgement.
- interventionNames
- Drug: Midazolam injection
- Drug: Fentanyl
- Drug: Propofol
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * patients aged 18-80 years, * clinical fit to undergo the planned procedure, according to the American Society of Anesthesiologists physical status classification. Exclusion Criteria: * current chronic opioid treatment, * substance abuse or drug use; * pregnancy, * history of allergy to related medications; * severe coagulation dysfunction; * severe hepatic * renal dysfunction; * history of abnormal recovery from anesthesia; * acute respiratory failure; * inability or unwillingness to provide informed consent.
References
Publications (3)
- RESULTWahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361. PMID 22045879
- RESULTAswanetmanee P, Limsuwat C, Kabach M, Alraiyes AH, Kheir F. The role of sedation in endobronchial ultrasound-guided transbronchial needle aspiration: Systematic review. Endosc Ultrasound. 2016 Sep-Oct;5(5):300-306. doi: 10.4103/2303-9027.191608. PMID 27803902
- RESULTScarlata S, Costa F, Pascarella G, Strumia A, Antonelli Incalzi R, Agro FE. Remifentanil Target-Controlled Infusion for Conscious Sedation in Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA): A Case Series. Clin Drug Investig. 2020 Oct;40(10):985-988. doi: 10.1007/s40261-020-00960-0. No abstract available. PMID 32767252