E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with suspicion of malignant pulmonary neoplasia who need an ecobronchoscopy under sedation |
Pacientes con sospecha de cáncer de pulmón que precisan un ecobroncoscopia con sedación |
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E.1.1.1 | Medical condition in easily understood language |
Lung cancer suspicion |
Sospecha de cáncer de pulmón |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Incidence of desaturation with sedation with dexmedetomidine during ecobronchoscopic procedures |
Incidencia de desaturación durante la sedación con dexmedetomidina en la ecobroncoscopia |
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E.2.2 | Secondary objectives of the trial |
To evaluate if dexmedetomidina: 1/ Reduce the number of rescue airway maneuvers to avoid desaturation 2/ Maintain haemodynamic stability 3/ Achieve a good sedation level for the procedure 4/ Allow a short recovery time 5/ Reduce the dose of remifentanil and topical lidocaine 6/ Achieve a good bronchoscopist and patient satisfaction |
Evaluar si la dexmedetomidina: 1/ Disminuye la necesidad de maniobras de rescate de la vía aérea para evitar la desaturación. 2/ Preserva la estabilidad hemodinámica. 3/ Mantiene un nivel de sedación necesario para la prueba. 4/ Permite un despertar rápido. 5/ Reduce la necesidad de remifentanilo y lidocaína 2% tópica. 6/ Consigue un grado de satisfacción del personal médico y del paciente adecuado. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients under 18 years Patients with suspicion of malignant pulmonary neoplasia who need an ecobronchoscopy under sedation Patients with signed informed consent |
Pacientes de ambos sexos mayores de 18 años de edad en el momento de la visita preoperatoria. Pacientes a los que se les realitzarà una EBUS por sospecha clínica de càncer de pulmón. Pacientes que firmen el consentimiento informado indicando que han sido informados de todos los aspectos pertinentes sobre el ensayo. |
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E.4 | Principal exclusion criteria |
Hypersensitivity to the active substance or to any of the included excipients Advanced heart block (grade 2 or 3) unless paced. Uncontrolled hypotension. Acute cerebrovascular conditions. |
Alergia o hipersensibilidad al principio activo o a alguno de los excipientes incluídos Hipotensión no controlada Bloqueo auriculoventricular grado 2 o 3 en ausencia de marcapassos Enfermedad cerebrovascular grave |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate if dexmedetomidina reduce de incidence of desaturation (SpO2 ? 92%) compared with propofol during the ecobronchoscopy procedures. |
Evaluar si la dexmedetomidina disminuye la incidencia de desaturación (SpO2 ? 92%) en comparación a propofol en pacientes sometidos a ecobroncoscopia. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Oxygen saturation will be recorded at T0, baseline; T1, after passage of the bronchoscope through vocal cords; T2, every 3 min after T1; T3, 10 min after the end of sedation; T4, at the time of patient discharge from the respiratory endoscopy unit. |
La saturación de oxígeno se determinará en el momento T0, basal; T1, tras el paso del ecobroncoscopio por las cuerdas vocales; T2, cada 3 min después de T1; T3, 10 min después de la retirada de la sedación; T4, en el momento de la salida del paciente de la sala de endoscopia respiratoria. |
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E.5.2 | Secondary end point(s) |
To evaluate if dexmedetomidina: 1/ Reduce the number of rescue airway maneuvers to avoid desaturation 2/ Maintain haemodynamic stability 3/ Achieve a good sedation level for the procedure 4/ Allow a short recovery time 5/ Reduce the dose of remifentanil and topical lidocaine 6/ Achieve a good bronchoscopist and patient satisfaction |
Evaluar si la dexmedetomidina: 1/ Disminuye la necesidad de maniobras de rescate de la vía aérea para evitar la desaturación. 2/ Preserva la estabilidad hemodinámica. 3/ Mantiene un nivel de sedación necesario para la prueba. 4/ Permite un despertar rápido. 5/ Reduce la necesidad de remifentanilo y lidocaína 2% tópica. 6/ Consigue un grado de satisfacción del personal médico y del paciente adecuado. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1/ Need for rescue airway manuevers during the whole procedure 2/ Heart rate, arterial pressure and presence of arrhythmias at T0, every 5 min from the start of sedation to the end of sedation and at the time of patient discharge from the respiratory endoscopy unit. 3/ Level of sedation after 15 min of the start of sedation, every 10 min during the procedure and at the time of patient discharge from the respiratory endoscopy unit. 4/ Recovery time mesured from the end of sedation to the complete concious recuperation 5/ Total dose of remifentanil and topical lidocaine at the end of the procedure 6/ Bronchoscopist satisfaction with the sedation at the end of the procedure. Patient satisfaction at the time of patient discharge from the respiratory endoscopy unit. |
1/Necesidad de maniobras de rescate de la vía aérea durante el procedimiento 2/Frecuencia cardíaca, presión arterial y aparición de arritmias en T0, cada 5 min desde en inicio de la sedación hasta el final de la misma y a la salida del paciente de la sala de endoscopia respiratoria 3/Nivel de sedación tras 15 min del inicio de la sedación, cada 10 min durante el procedimiento y a la salida del paciente de la sala de endoscopia respiratoria 4/Tiempo de despertar determinado entre la retirada de la sedación y la recuperación completa de la conciencia. 5/Consumo de remifentanilo y lidocaína tópica durante todo el procedimiento 6/Satisfacción del endoscopista con la sedación una vez finalizado el procedimiento. Satisfacción del paciente a salida de la sala de endoscopia respiratoria |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |