E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sedation in patients (whose colonoscopy has been scheduled) with inhalatory sevorane versus standard intravenous sedation. |
Sedación en pacientes programados para colonoscopia mediante sevoflurano inhalado frente a sedación intravenosa convencional. |
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E.1.1.1 | Medical condition in easily understood language |
Sedation in patients (whose colonoscopy has been scheduled) with inhalatory sevorane versus standard intravenous sedation. |
Sedación en pacientes programados para colonoscopia mediante sevoflurano inhalado frente a sedación intravenosa convencional. |
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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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049124 |
E.1.2 | Term | Sedation during medical procedure |
E.1.2 | System Organ Class | 100000004865 |
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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 compare the efficacy of sedation using a conventional intravenous technique versus another pure inhalation technique in patients scheduled for outpatient diagnostic and therapeutic colonoscopy. This effectiveness is to be determined by the quality of sedation as assessed by the endoscopist. |
Comparar la efectividad de la sedación mediante una técnica intravenosa convencional frente a otra técnica inhalatoria pura, en pacientes programados para colonoscopia diagnóstico-terapéutica en régimen ambulatorio. Dicha efectividad vendrá determinada por la calidad de la sedación según la valoración del endoscopista. |
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E.2.2 | Secondary objectives of the trial |
The specific objectives are: To compare the frequency of completed colonoscopies. To compare the frequency of patients with arterial desaturation, apnea or who require respiratory maneuvers to open the airway and ventilatory support. To compare the frequency of patients who present with movements which make exploration difficult. To compare the frequency of patients who develop cardiopulmonary complications. To compare the frequency of patients who present with over-sedation. To compare the frequency of hospital admissions. To compare the frequency of patients discharged after the first post-anesthetic assessment. To compare the extent of recovery 24 hours after exploration. To compare opinions and the satisfaction of patients. |
Comparar la frecuencia de colonoscopias terminadas. Comparar la frecuencia de pacientes que presentan desaturación arterial, apnea respiratoria o necesidad de maniobras de apertura de la vía aérea y asistencia ventilatoria. Comparar la frecuencia de pacientes que presentan movimientos que dificultan la exploración. Comparar la frecuencia de pacientes que desarrollan complicaciones cardiopulmonares. Comparar la frecuencia de pacientes que presentan sobresedación. Comparar la frecuencia de ingresos hospitalarios. Comparar la frecuencia de pacientes dados de alta tras la primera evaluación postanestésica. Comparar el grado de recuperación a las 24 horas de la exploración. Comparar la opinión y satisfacción de los pacientes . |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1) Patient scheduled to undergo outpatient diagnostic-therapeutic colonoscopy who are referred from health centers in the province of Castellón. (2) Age between 18 and 65 years of age. (3) Informed consent signed prior to inclusion in the study. |
(1) Paciente programado para realización de colonoscopia diagnóstico-terapéutica en régimen ambulatorio provenientes de centros de salud de la provincia de Castellón. (2) Tener más de 18 años de edad y menos de 65 años de edad. (3) Consentimiento Informado (CI) firmado anterior a la inclusión en el estudio |
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E.4 | Principal exclusion criteria |
(1) Refusal of the patient to participate in the study. (2) Minors (3) Pregnancy or lactation (4) History of liver or kidney disease. (5) History of psychotropic substance abuse (6) Psychiatric illness (7) Difficulty in communication with the patient for reasons of language or intellectual deficit. (8) Bearded patients, due to difficulties in achieving a facial mask seal. (9) Difficulty in placing the facial mask (facial injuries or malformations). (10) Scheduled double exploration (gastroscopy and colonoscopy). (11) Contraindication to any of the study drugs. (12) Allergies to any of the components of the study drugs. (13) Hemodynamic or respiratory instability or decompensation. (14) Worsening of concomitant disease described in the basline visit. |
(1) Rechazo del paciente a participar en el estudio. (2) Menores de edad. (3) Embarazo o lactancia. (4) Historia de enfermedad hepática o renal. (5) Historia de abuso de sustancias psicotropas. (6) Enfermedad psiquiátrica. (7) Dificultad para comunicarse con el paciente por razones de idioma o déficit intelectual. (8) Pacientes con barba, por dificultad con el sellado de la mascarilla facial. (9) Dificultad para colocar la mascarilla facial (heridas o malformaciones faciales). (10) Doble exploración programada (gastroscopia más colonoscopia). (11) Contraindicación de administración de algunos de los fármacos del estudio. (12) Alergias a alguno de los componentes de los fármacos del estudio. (13) Situación de inestabilidad o descompensación hemodinámica o respiratoria del paciente. (14) Agravamiento de alguna de las enfermedades concomitantes descritas en la visita basal |
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E.5 End points |
E.5.1 | Primary end point(s) |
The quality of sedation (during the colonoscopy) as assessed by the endoscopist. |
La calidad de la sedación durante la colonoscopia valorada por el endoscopista. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The statistical analysis is set out when 278 patients has been sedated in order to perform a colonoscopy. |
El análisis estadístico de resultados se realizará trás la sedación de 278 pacientes para la exploración por colonoscopia. |
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E.5.2 | Secondary end point(s) |
To compare the frequency of completed colonoscopies. To compare the frequency of patients with arterial desaturation, apnea or who require respiratory maneuvers to open the airway and ventilatory support. To compare the frequency of patients who present with movements which make exploration difficult. To compare the frequency of patients who develop cardiopulmonary complications. To compare the frequency of patients who present with over-sedation. To compare the frequency of hospital admissions. To compare the frequency of patients discharged after the first post-anesthetic assessment. To compare the extent of recovery 24 hours after exploration. To compare opinions and the satisfaction of patients. |
Comparar la frecuencia de colonoscopias terminadas. Comparar la frecuencia de pacientes que presentan desaturación arterial, apnea respiratoria o necesidad de maniobras de apertura de la vía aérea y asistencia ventilatoria. Comparar la frecuencia de pacientes que presentan movimientos que dificultan la exploración. Comparar la frecuencia de pacientes que desarrollan complicaciones cardiopulmonares. Comparar la frecuencia de pacientes que presentan sobresedación. Comparar la frecuencia de ingresos hospitalarios. Comparar la frecuencia de pacientes dados de alta tras la primera evaluación postanestésica. Comparar el grado de recuperación a las 24 horas de la exploración. Comparar la opinión y satisfacción de los pacientes. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The statistical analysis is set out when 278 patients has been sedated in order to perform a colonoscopy. |
El análisis estadístico de resultados se realizará trás la sedación de 278 pacientes para la exploración por colonoscopia. |
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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 | 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) | 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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LVLS |
LVLS : 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 |