E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
anaesthesia for prostate fusion biopsy in outpatient surgery |
anestesia en realización de la biopsia de próstata por fusión en cirugía ambulatoria |
|
E.1.1.1 | Medical condition in easily understood language |
anaesthesia for prostate biopsy in outpatient surgery |
anestesia en realización de la biopsia de próstata en cirugía ambulatoria |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004825 |
E.1.2 | Term | Biopsy of prostate |
E.1.2 | System Organ Class | 100000004848 |
|
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 |
To determine the effect dose 50 of prilocaine required to perform prostate fusion biopsy in patients undergoing surgery at AMC. |
Determinar la dosis efecto 50 de prilocaína requerida para realizar la biopsia de próstata por fusión en pacientes intervenidos en CMA |
|
E.2.2 | Secondary objectives of the trial |
- To assess the evolution of sensory and motor block after spinal anaesthesia. - To analyse the haemodynamic response during surgery (hypotension and/or bradycardia). - To know the incidence of DAP in the immediate postoperative period in this procedure. - To know the incidence of acute urinary retention in the immediate postoperative period. - To know the incidence of postoperative nausea and vomiting (PONV). - To know the average length of stay in the AMC Unit. - To determine the causes of delayed discharge from the unit. - To determine the incidence of unplanned admissions and their causes. |
- Evaluar la evolución del bloqueo sensitivo y motor tras la anestesia espinal - Analizar la respuesta hemodinámica durante la cirugía (hipotensión y/o bradicardia). - Conocer la incidencia de DAP en el postoperatorio inmediato en este procedimiento - Conocer la incidencia de retención aguda de orina en el postoperatorio inmediato. - Conocer la incidencia de náuseas y vómitos (NVPO) en el postoperatorio - Conocer la estancia media en la Unidad de CMA. - Conocer las causas de retraso en el alta de la unidad. - Conocer la incidencia de ingresos no previstos y sus causas |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-ASA I, ASA II and ASA III patients. - Aged 18-85 years, - Prostate fusion biopsy procedure - Signed informed consent |
-Pacientes ASA I, ASA II y ASA III. - Con edades entre 18-85 años, - Procedimiento de biopsia de próstata fusión - Firma del consentimiento informado |
|
E.4 | Principal exclusion criteria |
standard contraindications to neuraxial blockade, coagulopathy, site infection, neurological impairment, known allergy to local anaesthetics. |
contraindicaciones estándar al bloqueo neuraxial, coagulopatía, infección de la zona, el deterioro neurológico, alergia conocida a los anestésicos locales. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
positive cold response in L1-L2 |
respuesta positiva al frio en L1-L2 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
intraoperative |
intraoperatorio |
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E.5.2 | Secondary end point(s) |
hypotension and/or bradycardia sensory and motor block incidence of DAP incidence of acute urinary retention incidence of nausea and vomiting average length of stay in the AMC Unit causes of delayed discharge from the unit the incidence of unplanned admissions |
- - bloqueo sensitivo y motor - hipotensión y/o bradicardia. - incidencia de DAP - incidencia de retención aguda de orina -incidencia de náuseas y vómitos - estancia media en la Unidad de CMA. - causas de retraso en el alta de la unidad. - incidencia de ingresos no previstos y sus causas |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
evolution of sensory and motor block after spinal anaesthesia. haemodynamic response during surgery (hypotension and/or bradycardia). incidence of DAP in the immediate postoperative period incidence of acute urinary retention in the immediate postoperative period. incidence of postoperative nausea and vomiting (PONV). average length of stay in the AMC Unit. |
evolución del bloqueo sensitivo y motor tras la anestesia espinal respuesta hemodinámica durante la cirugía (hipotensión y/o bradicardia). la incidencia de DAP en el postoperatorio inmediato incidencia de retención aguda de orina en el postoperatorio inmediato. incidencia de náuseas y vómitos (NVPO) en el postoperatorio estancia media en la Unidad de CMA. |
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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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
|
LVLS(telephonic contact 24h after discharge) |
UVUP( contacto telefónico 24 horas despues del alta ) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |