Dexmedetomidine as an add-on Sedative for Endobronchial Ultrasound
Conscious Sedation · Lung Neoplasms · Lymphadenopathy (Mediastinal)
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 40 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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).
¿Quién podría participar?
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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
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
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
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Patient Discomfort Assessed by Visual Analogue Scale
Plazo: 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
Plazo: Baseline/Day 1
Procedural difficulty rated by the bronchoscopist on a 0-10 visual analogue scale (0 = no difficulty, 10 = worst imaginable difficulty).
Medidas secundarias
Procedure Duration
Plazo: Periprocedural
Duration of the procedure, in minutes.
Recovery Time
Plazo: Day 1
Time from the end of the procedure to discharge from the recovery area, in minutes.
Total Midazolam Dose
Plazo: Periprocedural
Cumulative midazolam dose administered, in mg.
Total Fentanyl Dose
Plazo: Periprocedural
Cumulative fentanyl dose administered, in µg.
Lowest Mean Arterial Pressure
Plazo: Periprocedural
Lowest mean arterial pressure recorded during the procedure, in mmHg.
Change in Mean Arterial Pressure
Plazo: Periprocedural
Baseline minus lowest intraprocedural mean arterial pressure, in mmHg
Lowest Heart Rate
Plazo: Periprocedural
Lowest heart rate recorded during the procedure, in beats per minute.
Change in Heart Rate
Plazo: Periprocedural
Baseline minus lowest intraprocedural heart rate, in beats per minute.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
João FreitasLisbon, Lisbon District, PortugalEstado desconocido
Equipo y fechas
- Patrocinador principal
- Centro Hospitalar de Lisboa Central
- Inicio del estudio
- 1 abr 2026 Real
- Finalización primaria
- 30 jun 2026 Real
- Finalización del estudio
- 31 jul 2026 Real
- Primera publicación
- 9 nov 2026 Real
- Última actualización
- 9 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Dexmedetomidine as an Adjunct to Midazolam-Fentanyl Sedation During Endobronchial Ultrasound: a Randomised Controlled Trial
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026