E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Arthroscopy for Temporomandibular |
Artroscopia temporomaxilar |
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E.1.1.1 | Medical condition in easily understood language |
Arthroscopy for Temporomandibular |
Artroscopia temporomaxilar |
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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 |
Assessment of postoperative nausea and vomiting in temporomandibular joint arthroscopy comparing 3 anesthetic maintenance regimens used in routine clinical practice. |
Valoración de la presentación de náuseas y vómitos en el postoperatorio en artroscopia de la articulación temporomandibular comparando 3 régimen de mantenimiento anestésico utilizados en la práctica clínica habitual. |
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E.2.2 | Secondary objectives of the trial |
1. Evaluation of the patient's comfort, in terms of pain, delayed awakening, stay in a post-anesthetic recovery unit (URPA) and hospital. 2. Determination of the incidence of cardiovascular events, respiratory events (such as episodes of bronchoconstriction) and intraoperative awakenings. |
1. Evaluación del Confort del paciente, en términos de dolor, retraso en el despertar, estancia en unidad de recuperación postanestésica (URPA) y hospitalaria. 2. Determinación de la incidencia de eventos cardiovasculares, respiratorios (como por ejemplo episodios de broncocostricción) y de despertares intraoperatorios.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients undergoing arthroscopy of the temporomandibular joint due to dysfunction of the joint. • Patients older than 18 and younger than 99 years. • ASA Classification I-II-III • Patients who have signed informed consent • In the case of women of childbearing age, they should have a negative pregnancy test. |
•Pacientes sometidos a una artroscopia de la articulación temporomandibular debido a disfunción de la misma. •Pacientes mayores de 18 años y menores de 99 años. •Clasificación ASA I-II-III •Pacientes que hayan firmado el consentimiento informado •En el caso de mujeres en edad fértil, deben tener un test de embarazo negativo.
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E.4 | Principal exclusion criteria |
• Patients with known allergy to some of the drugs used. • Patients with intellectual or psychiatric problems that prevent them from fully understanding informed consent. • Patients with severe heart disease (NYHA Grade III and IV) • Severe renal disease (creatinine clearance ≤ 30 mL / min) • Liver disease (Child-Pugh Grade C) • Patients with type I or II diabetes mellitus, compensated or decompensated |
•Pacientes con alergia conocida a algunos de los fármacos utilizados. •Pacientes con problemas intelectuales o psiquiátricos que les impidan comprender completamente el consentimiento informado. •Pacientes con enfermedad cardíaca severa (Grado III y IV de la NYHA) •Enfermedad renal severa (aclaramiento de creatinina ≤ 30 mL/min) •Enfermedad hepática (Grado C de Child-Pugh) •Pacientes con diabetes mellitus tipo I o II, compensados o descompensados
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E.5 End points |
E.5.1 | Primary end point(s) |
Presence of PONV at 2, 6 and 24 postoperative hours, taking into account the intensity scale of PONV and the visual analog scale of nausea. |
Presencia de NVPO a las 2, 6 y 24 horas postoperatorias, teniendo en cuenta la escala de intensidad de NVPO y la escala analógica visual de náuseas. |
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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) |
Demographic variables: • Sex • Age • Weight • Height • Body mass index • Toxic habits (tobacco and enolics), • Clinical Variables: Anesthetic risk ASA (American Society of Anesthesiologists) • Mean arterial pressure and heart rate at admission to the plant. • Usual medication • History of postoperative dizziness, nausea and vomiting • Medical and surgical history • Duration of anesthesia and surgery • Temperature • Volume and type of fluids administered • Time from drug discontinuation to extubation. • Time to wake up from stopping anesthetic drugs • Administered drugs (type and dose) • Time to start: oral tolerance and mobilization • Length of stay in Post Anesthesia Recovery Unit (URPA) and length of hospital stay • Pain through visual analog scale (EVA) • Postoperative analgesia (rescue analgesic requirements) • Need for antiemetic medication |
•Variables demográficas: •Sexo •Edad •Peso •Altura •Índice de masa corporal •Hábitos tóxicos (tabáquicos y enólicos), •Variables Clínicas: Riesgo anestésico ASA (American Society of Anesthesiologists) •Tensión arterial media y frecuencia cardiaca a la admisión en la planta. •Medicación habitual •Antecedentes de mareos, náuseas y vómitos postoperatorios •Antecedentes médicos y quirúrgicos •Duración de la anestesia y de la cirugía •Temperatura •Volumen y tipo de fluidos administrados •Tiempo desde la interrupción de fármacos hasta extubación. •Tiempo en despertar desde que se paran los fármacos anestésicos •Fármacos administrados (tipo y dosis) •Tiempos hasta que inicia: la tolerancia oral y la movilización •Tiempo de estancia en Unidad de Recuperación Post Anestésica (URPA) y tiempo de estancia hospitalaria •Dolor mediante la escala analógica visual (EVA) •Analgesia postoperatoria (requerimientos de analgésicos de rescate) •Necesidad de medicación antiemética
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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 | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
COMPARATIVO DE NÁUSEAS Y VÓMITOS EN TRES REGÍMENES ANESTÉSICOS: INTRAVENOSO, INHALATORIO Y MIXTO |
COMPARATIVE OF NÁUSEAS AND VOMITING IN THREE ANESTHETICAL REGIMENS: INTRAVENOUS INHALATORY AND MIXED |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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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The last visit of the last patient |
La última visita del último paciente |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |