E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients scheduled for supratentorial craniotomy or brainstem surgery with intraoperative monitoring of motor evoked potentials (MEP). |
Pacientes programados para craneotomía supratentorial o de tronco cerebral, con monitorización intraoperatoria de potenciales evocados motores (PEM). |
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E.1.1.1 | Medical condition in easily understood language |
Patients scheduled for brain surgery with nervous central system monitoring. |
Pacientes programados para cirugía cerebral con monitorización del sistema nervioso central. |
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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 |
During craniotomy procedures with monitoring of motor evoked potentials (MEP), we wanted to compare at baseline (before initiating craniotomy) the stimulation intensity and amplitude of MEP in patients allocated to receive either: propofol, remifentanil (PR group) or propofol,remifentanil,dexmedetomidine(PRD group) |
En pacientes programados para craneotomías con monitorización intraoperatoria de potenciales evocados motores (PEM), comparar entre el grupo propofol-remifentanilo (PR) y el grupo propofol-remifentanilo-dexmedetomidina (PRD): Intensidad de estimulación y amplitud de los PEM basal (antes del inicio de la craneotomía.
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E.2.2 | Secondary objectives of the trial |
1-Propofol and remifentanil requirements 2- Total consumption of propofol and remifentanil 3- Latency and amplitude of somatosensory evoked potentials (SSEP) 4- Mean arterial pressure, heart rate, oxygen saturation (SpO2)and bispectral index (BIS) 5- Time to wake up from anaesthesia 6- Side effects 7- Postoperative analgesics requirements |
1-Requerimientos de propofol y remifentanilo basal (antes del inicio de la craneotomía) 2-Consumo total de propofol y remifentanilo. 3- Latencia y amplitud de los PESS. 4- Presión arterial media, frecuencia cardíaca, saturación de oxígeno (SpO2), e índice biespectral (BIS) 5- Tiempo de despertar al finalizar la cirugía. 6- Aparición de efectos adversos. 7- Consumo de analgésicos postoperatorios
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Male and females over 18 years. 2- Patients undergoing supratentorial craniotomy or brainstem surgery due to tumors located in these areas. 3- Patients who have given the informed written consent. |
1. Pacientes de ambos sexos mayores de 18 años de edad en el momento de la visita preoperatoria. 2. Pacientes que serán intervenidos de lesiones tumorales localizadas en el tronco encefálico y a nivel supratentorial bajo anestesia general endovenosa a los que se realizará monitorización neurofisiológica. 3. 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 |
Patients with hypovolemic shock or atrioventricular block Patients with liver disease ( altered transaminases) Motor and sensory deficit prior preoperative anaesthetic evaluation Moderate- severe renal insufficiency( creatinine clearance< 60 ml/min) Allergy or hypersensitivity to drugs or excipients used in the study Pregnancy Patients who have entered in other study, three months before surgery
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1. Pacientes que presentan datos clínicos de shock hipovolémico o bloqueo auriculo-ventricular completo. 2. Pacientes con insuficiencia hepática (transaminasas alteradas). 3. Pacientes con déficit motor o sensitivo previo a la intervención causados o no por la lesión. 4. Pacientes con insuficiencia renal moderada-severa. Aquellos con aclaramiento de creatinina < 60 mL/min serán excluidos. 5. Alergia o hipersensibilidad al principio activo o a alguno de los excipientes de los fármacos del ensayo clínico (ver anexo 1, ficha técnica). 6. Mujeres embarazadas o en periodo de lactancia. 7. Participación en alguna investigación clínica dentro de los 3 meses anteriores a la administración del fármaco.
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E.5 End points |
E.5.1 | Primary end point(s) |
During craniotomy procedures with monitoring of motor evoked potentials (MEP), we wanted to compare at baseline (before initiating craniotomy) the threshold intensity and amplitude of MEP in patients allocated to receive either: propofol, remifentanil (PR group) or propofol,remifentanil,dexmedetomidine(PRD group) |
En pacientes programados para craneotomías con monitorización intraoperatoria de potenciales evocados motores (PEM), comparar entre el grupo propofol-remifentanilo (PR) y el grupo propofol-remifentanilo-dexmedetomidina (PRD): Intensidad umbral y amplitud de los PEM basal (antes del inicio de la craneotomía.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At thirty minutes, forty - five minutes and sixty minutes after anaesthetic induction |
A los 30 minutos, 45 minutos y 60 minutos después de la inducción anestésica |
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E.5.2 | Secondary end point(s) |
1- Propofol (mg/kg/h) and remifentanil (ug/kg/min) requirements at baseline. 2- Total doses of propofol (mg/kg/h) and remifentanil (ug/kg/min). 3- Latency and amplitude of somatosensory evoked potentials. 4- Mean arterial pressure, heart rate, oxygen saturation by pulse oximetry, bispectral index. 5- Time to wake up. 6- Occurrence of side effects. 7- Postoperative analgesics consumption.
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1-Requerimientos de propofol y remifentanilo basal (antes del inicio de la craneotomía) 2-Consumo total de propofol y remifentanilo. 3- Latencia y amplitud de los PESS. 4- Presión arterial media, frecuencia cardíaca, saturación de oxígeno (SpO2), e índice biespectral (BIS) 5- Tiempo de despertar al finalizar la cirugía. 6- Aparición de efectos adversos. 7- Consumo de analgésicos postoperatorios
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1- At baseline (before initiating craniotomy). 2- From anaesthetic induction to the end of surgery. 3- 30, 45, and 60 minutes after anaesthetic induction. 4- Every 5 minutes during anaesthetic induction and surgery. Every 15 minutes in recovery room. 5- From the end of surgery to the verbal response of the patient. 6- During the study. 7- Postoperative 24 h.
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1-Requerimientos de propofol y remifentanilo basal (antes del inicio de la craneotomía) 2-Consumo total de propofol y remifentanilo (desde la inducción anestésica hasta el final de la cirugía). 3- Latencia y amplitud de los PESS (durante la cirugía). 4- Presión arterial media, frecuencia cardíaca, saturación de oxígeno (SpO2), e índice biespectral (BIS) (cada 5 minutos durante la cirugía y cada quince minutos en sala de Reanimación 5- Tiempo de despertar al finalizar la cirugía (desde el final de la cirugía hasta la respuesta verbal del paciente) 6- Aparición de efectos adverso (durante el estudio) 7- Consumo de analgésicos postoperatorios en 24 h.
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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 | No |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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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Last visit of the last recruited patient. |
Última visita del último paciente reclutado. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |