Dexmedetomidine as an add-on Sedative for Endobronchial Ultrasound

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 40 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Age ≥ 18 years
Scheduled for elective EBUS-TBNA or radial EBUS under moderate sedation
Able to understand the study and provide written informed consent

Exclusion Criteria:

Previous hypersensitivity reaction to the substances involved
2nd or 3rd degree heart blockage without an implanted pacemaker
bradycardia (\<60bpm) or hypotension (\<90/60mmHg) at the time of enrollment
recent (\<3 months) acute cerebrovascular event

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Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Control group: Midazolam-fentanyl

Arm type: Active Comparator Description: Midazolam 1 mg and fentanyl 25 µg boluses titrated to RASS -1 to 0.

Drug: Midazolam · Drug: fentanyl

Dexmedetomidine + midazolam-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

Dexmedetomidine DRUG

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

Midazolam DRUG

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

fentanyl DRUG

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Patient Discomfort Assessed by Visual Analogue Scale

Time frame: Baseline/Day 1

Patient-reported discomfort during the procedure, measured on a 0-10 visual analogue scale (0 = no discomfort, 10 = worst imaginable discomfort).

Physician-Rated Procedural Difficulty Assessed by Visual Analogue Scale

Time frame: Baseline/Day 1

Procedural difficulty rated by the bronchoscopist on a 0-10 visual analogue scale (0 = no difficulty, 10 = worst imaginable difficulty).