E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intra-operative adverse events during laparoscopic surgery |
Seguridad intraoperatoria en cirugía laparoscópica |
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E.1.1.1 | Medical condition in easily understood language |
Adverse events during laparoscopic surgery |
Seguridad en cirugía laparoscópica |
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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 |
To study the effect of deep neuromuscular block compared to standard neuromuscular block on intra- operative adverse events during laparoscopic surgery using the CLASSIC score system. |
Estudiar el efecto del bloqueo neuromuscular profundo en comparación con el bloqueo neuromuscular estándar en los eventos adversos intraoperatorios durante la cirugía laparoscópica utilizando el sistema de puntuación CLASSIC. |
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E.2.2 | Secondary objectives of the trial |
To study the effect of deep neuromuscular block as compared to standard neuromuscular block on: • Surgical working conditions (L-SRS) • 30 day post-operative complications (Clavien-Dindo) • 30-day post-operative complications according to the Comprehensive Complication Index • 30 day unplanned readmission rates
Quality of recovery at post-operative day 1, 2 and 30 after laparoscopic surgery. -Quality-of-recovery (QoR-40 at postoperative day 1 and 2; Aldrete score at the PACU) -Quality-of-life at postoperative day 30 (SF36) |
Estudiar el efecto del bloqueo neuromuscular profundo en comparación con el bloqueo neuromuscular estándar en: • Condiciones de trabajo quirúrgicas (L-SRS) • Complicaciones postoperatorias a 30 días (Clavien-Dindo) • Complicaciones postoperatorias de 30 días según el Índice de complicaciones completas • Tasas de readmisión no planificada de 30 días
-Calidad de la recuperación en el postoperatorio los días 1, 2 y 30 después de la cirugía laparoscópica. -Calidad de recuperación (QoR-40 en los días 1 y 2 del postoperatorio; puntuación de Aldrete en la PACU) -Calidad de vida en el día 30 postoperatorio (SF36) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a patient must meet all of the following criteria: • Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: ‘MAJOR’, ‘MAJOR PLUS’ or ‘COMPLEX MAJOR’ • ASA class I-III • > 18 years of age • Ability to give oral and written informed consent |
Para ser elegible para participar en este estudio, un paciente debe cumplir con todos los siguientes criterios: • Pacientes con cirugía laparoscópica programada, sleccionado con una complejidad según la clasificación BUPA de: "MAYOR", "MAYOR PLUS" o "MAYOR COMPLEJO" • ASA clase I-III •> 18 años de edad • Capacidad para dar consentimiento informado oral y escrito. |
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E.4 | Principal exclusion criteria |
• Low or intermediate complexity laparoscopic procedures (BUPA ‘SIMPLE’ or ‘INTER’) • Known or suspected neuromuscular disorders impairing neuromuscular function • Allergies to muscle relaxants, anesthetics or narcotics • A (family) history of malignant hyperthermia • Women who are or may be pregnant or are currently breast feeding • Chronic use of any type of opioid or psychotropic drug • Use of NSAID’s shorter than 5 days before surgery • Indication for rapid sequence induction • Contra-indication for sugammadex use (e.g. known sugammadex allergy or GFR<30 ml/min) |
Procedimientos laparoscópicos de complejidad baja o intermedia (BUPA ‘SIMPLE’ o ‘INTER’) • Trastornos neuromusculares conocidos o sospechosos que afectan la función neuromuscular • Alergias a relajantes musculares, anestésicos o narcóticos • Antecedentes (familiares) de hipertermia maligna. • Mujeres que están o pueden estar embarazadas o están amamantando. • Uso crónico de cualquier tipo de opioide o psicotrópico. • Uso de AINES de menos de 5 días antes de la cirugía • Indicación para inducción de secuencia rápida. • Contraindicación para el uso de sugammadex (por ejemplo, alergia conocida a sugammadex o GFR <30 ml / min) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Intra-operative adverse events evaluated with the CLASSIC Score form |
Efectos adversos intra-operatorios evaluados con el formulario CLASSIC Score |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
during laparoscopic surgery |
durante la cirugía laparoscópica |
|
E.5.2 | Secondary end point(s) |
Study the effect of deep neuromuscular block as compared to standard neuromuscular block on: • Surgical working conditions (L-SRS) • 30 day post-operative complications (Clavien-Dindo) • 30-day post-operative complications according to the Comprehensive Complication Index • 30 day unplanned readmission rates • Quality of recovery at post-operative day 1, 2 and 30 after laparoscopic surgery. o Quality-of-recovery (QoR-40 at postoperative day 1 and 2; Aldrete score at the PACU) o Quality-of-life at postoperative day 30 (SF36) |
Estudiar el efecto del bloqueo neuromuscular profundo en comparación con el bloqueo neuromuscular estándar en: • Condiciones de trabajo quirúrgicas (L-SRS) • Complicaciones postoperatorias a 30 días (Clavien-Dindo) • Complicaciones postoperatorias de 30 días según el Índice de complicaciones completas • Tasas de readmisión no planificada de 30 días • Calidad de recuperación en el postoperatorio los días 1, 2 y 30 después de la cirugía laparoscópica. o Calidad de recuperación (QoR-40 en el día 1 y 2 postoperatorios; puntuación de Aldrete en la URPA) o Calidad de vida en el día 30 postoperatorio (SF36) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the 30 post-operative days. |
Durante los 30 días post-operatorios. |
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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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
El mismo medicamento con diferentes dosis |
The same medicinal product with different doses |
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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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |