An interventional study of Dexmedetomidine and Midazolam in Conscious Sedation, Lung Neoplasms and Lymphadenopathy (Mediastinal), sponsored by Centro Hospitalar de Lisboa Central. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Centro Hospitalar de Lisboa Central · Not applicable, Interventional, and Supportive care
Endobronchial ultrasound (EBUS) is commonly performed under moderate sedation with midazolam and fentanyl, but patients may still experience discomfort and procedures can be technically demanding. Dexmedetomidine is a sedative that causes little respiratory depression. This randomized trial evaluated whether adding a continuous dexmedetomidine infusion to standard midazolam-fentanyl sedation reduces patient discomfort and procedural difficulty during EBUS, compared with midazolam-fentanyl alone.
This was a single-centre, randomized, parallel-group trial conducted at the Pulmonology Interventional Techniques Unit, Hospital de Santa Marta (ULS São José, Lisbon, Portugal). Adults scheduled for elective EBUS-guided transbronchial needle aspiration (EBUS-TBNA) or radial EBUS under moderate sedation were randomized 1:1, using a computer-generated sequence, to midazolam-fentanyl sedation alone (control) or midazolam-fentanyl plus dexmedetomidine.
In the intervention arm, dexmedetomidine (4 µg/mL) was infused at a fixed rate of 0.7 µg/kg/h, without a loading dose, starting 15 minutes before the procedure. In both arms, sedation was titrated with intravenous boluses of midazolam 1 mg and fentanyl 25 µg to a Richmond Agitation-Sedation Scale (RASS) score of -1 to 0, and the procedure started once this target was reached. All patients received standard monitoring and maximal supplemental oxygen.
Primary outcomes were patient discomfort and physician-rated procedural difficulty, each measured on a 0-10 visual analogue scale. Secondary outcomes were procedure duration, recovery time, total midazolam and fentanyl doses, and haemodynamic parameters (lowest mean arterial pressure and heart rate during the procedure, and their change from baseline).
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Centro Hospitalar de Lisboa Central is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm type: Active Comparator Description: Midazolam 1 mg and fentanyl 25 µg boluses titrated to RASS -1 to 0.
Drug: Midazolam · Drug: fentanyl
Continuous dexmedetomidine infusion at 0.7 µg/kg/h, without a loading dose, started 15 minutes before the procedure, in addition to midazolam 1 mg and fentanyl 25 µg boluses titrated to RASS -1 to 0.
Drug: Dexmedetomidine · Drug: Midazolam · Drug: fentanyl
Arm type: Experimental Description: Continuous dexmedetomidine infusion at 0.7 µg/kg/h, without a loading dose, started 15 minutes before the procedure, in addition to midazolam 1 mg and fentanyl 25 µg boluses titrated to RASS -1 to 0. Intervention: Dexmedetomidine only in the intervention group Midazolam and fentanyl in both groups
Description: Arm type: Experimental Description: Continuous dexmedetomidine infusion at 0.7 µg/kg/h, without a loading dose, started 15 minutes before the procedure, in addition to midazolam 1 mg and fentanyl 25 µg boluses titrated to RASS -1 to 0. Intervention: Dexmedetomidine only in the intervention group Midazolam and fentanyl in both groups
Description: Arm type: Experimental Description: Continuous dexmedetomidine infusion at 0.7 µg/kg/h, without a loading dose, started 15 minutes before the procedure, in addition to midazolam 1 mg and fentanyl 25 µg boluses titrated to RASS -1 to 0. Intervention: Dexmedetomidine only in the intervention group Midazolam and fentanyl in both groups
Patient Discomfort Assessed by Visual Analogue Scale
Patient-reported discomfort during the procedure, measured on a 0-10 visual analogue scale (0 = no discomfort, 10 = worst imaginable discomfort).
Time frame: Baseline/Day 1
Physician-Rated Procedural Difficulty Assessed by Visual Analogue Scale
Procedural difficulty rated by the bronchoscopist on a 0-10 visual analogue scale (0 = no difficulty, 10 = worst imaginable difficulty).
Time frame: Baseline/Day 1
Procedure Duration
Duration of the procedure, in minutes.
Time frame: Periprocedural
Recovery Time
Time from the end of the procedure to discharge from the recovery area, in minutes.
Time frame: Day 1
Total Midazolam Dose
Cumulative midazolam dose administered, in mg.
Time frame: Periprocedural
Total Fentanyl Dose
Cumulative fentanyl dose administered, in µg.
Time frame: Periprocedural
Lowest Mean Arterial Pressure
Lowest mean arterial pressure recorded during the procedure, in mmHg.
Time frame: Periprocedural
Change in Mean Arterial Pressure
Baseline minus lowest intraprocedural mean arterial pressure, in mmHg
Time frame: Periprocedural
Lowest Heart Rate
Lowest heart rate recorded during the procedure, in beats per minute.
Time frame: Periprocedural
Change in Heart Rate
Baseline minus lowest intraprocedural heart rate, in beats per minute.
Time frame: Periprocedural
Plan to share: No — Individual participant data will not be shared, as data sharing was not covered by the participants' informed consent or the ethics committee approval. Aggregated results are reported in the published manuscript.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dexmedetomidine
Centro Hospitalar de Lisboa Central