E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Propofol´s mean dosage in routinely esophagogastroduodenoscopy with and without topical pharyngeal anaesthesia with lidocaine. Variation between the patient´s groups in side effects and endoscopist and ansesthetist´s satisfaction. |
La dosificación promedio de propofol administrada en esofagogastroduodenoscopias bajo sedación con propofol con y sin asnestesia mediante lidocaina tópica faríngea. Y variación en la incidencia de efectos adversos y satisfacción entre ambos grupos para el endoscopista y anestesista. |
|
E.1.1.1 | Medical condition in easily understood language |
Variations in the incidence of side effects and mean dosage of propofol in gastrointestinal endoscopy with the application of topical pharyngeal anaesthesia. |
Variaciones en la incidencia de efectos adversos y dosis de propofol en endoscopia digestiva con y sin la aplicación de anestesia faríngea. |
|
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 |
Comparate mean dosage of propofol between similar groups of patients that receive placebo vs 50 mg of topical lidocaine before esophagogastroduodenoscopy. |
Comparación de la dosis media de propofol entre grupos similares de pacientes que recibiran placebo o 50 mg de lidocaina tópica previa a esofagogastroduodenoscopia. |
|
E.2.2 | Secondary objectives of the trial |
-Incidence of side effects -Satisfaction of endoscopist -Satisfaction of anaesthetist -Realationship with Mallampati´s index |
-Incidencia de efectos adversos -Satisfacción del endoscopista -Satisfacción del anestesista -Relación con el índice de Mallampati |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient´s over 18 years old that received standard indication for sedated esophagogastroduodenoscopy (American Society of Gastroinestinal Endoscopy Guidelines) in our centre between the period of study. |
Pacientes mayores de 18 años con indicación por consenso (criterios de la Sociedad Americana de Endoscopia Digestiva) para esofagogastroduodenoscopia con sedación en nuestro centro en el periodo del estudio. |
|
E.4 | Principal exclusion criteria |
-Patients under 18 years old -Unable to obtain inform´s consent -Emergency endoscopy -Pregnant women -Encephalopathy -Well known allergic reaction to propofol, amide-anaesthesics, soy or eggs -Methaemogloninemia induced factor risks -No previous or unknown fasting |
-Pacientes menores de 18 años -Incapacidad para la obtención del consentimiento informado -Endoscopia urgente -Mujeres embarazadas -Encefalopatía -Reacción alérgica conocida a propofol, soja, huevos, anestésicos del grupo amida -Metahemoglobinemia o sus factores de riesgo -Ayuno no respectado o desconocido |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Reach the inclusion in the study of 120 patients prestablished (60 ASA I-II and 60 ASA III-IV) and double blind randomized between placebo and lidocaine groups. |
-Alcance del tamaño muestral predefinido a 120 pacientes (60 ASA I-II y 60 ASA III-IV) en una aleatorización randomizada doble ciego entre los grupos de placebo y lidocaina tópica |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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
|
The end of the trial will considered when the insurance contract period expired, all patients included until this point will be analyzed. |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 15 |