E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
AGITATION AFTER POSTOPERATIVE ANESTHESIA IN PEDIATRIC PATIENTS |
AGITACIÓN POSTOPERATORIA EN PACIENTES PEDIÁTRICOS TRAS ANESTESIA |
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E.1.1.1 | Medical condition in easily understood language |
AGITATION AFTER POSTOPERATIVE ANESTHESIA IN PEDIATRIC PATIENTS |
AGITACIÓN POSTOPERATORIA EN PACIENTES PEDIÁTRICOS TRAS ANESTESIA |
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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 |
Assess the incidence and characteristics of postoperative agitation in pediatric patients undergoing general anesthesia with sevoflurane or desflurane combined with a technique of regional anesthesia for peripheral intra and postoperative analgesia for ambulatory surgery procedures (CMA). |
Evaluar la incidencia y características de la agitación postoperatoria en pacientes pediátricos sometidos a anestesia general con sevoflurano ó desflurano combinados con una técnica de anestesia regional periférica para analgesia intra y postoperatoria, para procedimientos de cirugía mayor ambulatoria (CMA). |
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E.2.2 | Secondary objectives of the trial |
a) Assessment of other factors that may influence postoperative agitation: demographics (age, gender), degree of postoperative anxiety, premedication, duration of anesthesia and surgery, intraoperative and postoperative events, postoperative pain, and time stay at Unit Post-Anesthesia Recovery (PACU). b) Monitoring (by telephone) during the first 24 hours of the patient after discharge, and evaluation of possible side effects of anesthesia. Track 7 days for patients who developed complications 24 hours. |
a) Evaluación de otros factores que puedan influir en la agitación postoperatoria: datos demográficos (edad, sexo), grado de ansiedad postoperatoria, premedicación, duración de la anestesia y de la cirugía, incidencias intraoperatorias y postoperatorias, dolor en el postoperatorio, y tiempo de estancia en la Unidad de Recuperación Post-Anestésica (URPA). b) Seguimiento (mediante llamada telefónica) durante las primeras 24 horas del paciente tras el alta hospitalaria, y evaluación de posibles efectos secundarios de la anestesia. Seguimiento a los 7 días de aquellos pacientes que presentaron alguna complicación las primeras 24 horas. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients 1-10 years. 2. Risk anesthetic ASA (American Society of Anesthesiologists) I or II. 3. Scheduled for ambulatory surgery procedures (herniorrhaphies, phimosis, prepucioplastias, orchidopexies). 4. Fasting 6 hours for regular formula or solid foods from 4 hours to breast milk, and 2 hours for water. 5. whose parents and / or legal representatives, subjects agree to participate in the study by signing the informed consent. |
1. Pacientes de 1 a 10 años. 2. Riesgo anestésico ASA (American Society of Anesthesiologists) I ó II. 3. Programados para procedimientos de cirugía mayor ambulatoria (herniorrafias, fimosis, prepucioplastias, orquidopexias). 4. Ayunas de 6 horas para alimentos sólidos ó fórmulas regulares, de 4 horas para leche materna, y de 2 horas para agua. 5. Sujetos cuyos padres y/o representantes legales, acepten participar en el estudio mediante la firma del consentimiento informado. |
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E.4 | Principal exclusion criteria |
1. Patients 1-10 years. 2. Risk anesthetic ASA (American Society of Anesthesiologists) I or II. 3. Scheduled for ambulatory surgery procedures (herniorrhaphies, phimosis, prepucioplastias, orchidopexies). 4. Fasting 6 hours for regular formula or solid foods from 4 hours to breast milk, and 2 hours for water. 5. Whose parents and / or legal Representatives, subjects agree to Participate in the study by signing the informed consent. |
1. Patients 1-10 years. 2. Risk anesthetic ASA (American Society of Anesthesiologists) I or II. 3. Scheduled for ambulatory surgery procedures (herniorrhaphies, phimosis, prepucioplastias, orchidopexies). 4. Fasting 6 hours for regular formula or solid foods from 4 hours to breast milk, and 2 hours for water. 5. whose parents and / or legal representatives, subjects agree to participate in the study by signing the informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assess the incidence and characteristics of postoperative agitation in pediatric patients undergoing general anesthesia with sevoflurane or desflurane combined with a technique of regional anesthesia for peripheral intra and postoperative analgesia for ambulatory surgery procedures (CMA) mainly herniorrhaphies, circumcisions, surgeries hydrocele, prepucioplastias and orchidopexies. |
Evaluar la incidencia y características de la agitación postoperatoria en pacientes pediátricos sometidos a anestesia general con sevoflurano ó desflurano combinados con una técnica de anestesia regional periférica para analgesia intra y postoperatoria, para procedimientos de cirugía mayor ambulatoria (CMA) principalmente herniorrafias, circuncisiones, cirugías de hidrocele, prepucioplastias y orquidopexias. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
a) Assessment of other factors that may influence postoperative agitation: demographics (age, gender), degree of preoperative anxiety, premedication, duration of anesthesia and surgery, intraoperative and postoperative events, postoperative pain, and time stay at Unit Post-Anesthesia Recovery (PACU). b) Monitoring (by telephone) during the first 24 hours of the patient after discharge, and evaluation of possible side effects of anesthesia. Track 7 days for patients who developed complications 24 hours. |
a) Evaluación de otros factores que puedan influir en la agitación postoperatoria: datos demográficos (edad, sexo), grado de ansiedad preoperatoria, premedicación, duración de la anestesia y de la cirugía, incidencias intraoperatorias y postoperatorias, dolor en el postoperatorio, y tiempo de estancia en la Unidad de Recuperación Post-Anestésica (URPA). b) Seguimiento (mediante llamada telefónica) durante las primeras 24 horas del paciente tras el alta hospitalaria, y evaluación de posibles efectos secundarios de la anestesia. Seguimiento a los 7 días de aquellos pacientes que presentaron alguna complicación las primeras 24 horas. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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 | Yes |
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) | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |