E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Reversal of rocuronium-induced neuromuscular blockade |
Recupero della funzionalità muscolare dopo blocco neuromuscolare
indotto da rocuronio |
|
E.1.1.1 | Medical condition in easily understood language |
Reversal of rocuronium-induced neuromuscular blockade |
Recupero della funzionalità muscolare dopo blocco neuromuscolare
indotto da rocuronio |
|
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 |
Comparison of the recovery time from neuromuscular blockade after
administration of sugammadex e neostigmine in morbidly obese patients |
Confronto tra il tempo di recupero dal blocco neuromuscolare dopo
somministrazione di sugammadex e neostigmina in pazienti con obesità
patologica |
|
E.2.2 | Secondary objectives of the trial |
Postoperative pulmonary function evaluation after sugammadex and
neostigmine administration for recovery of neuromuscular blockade in
patients undergoing laparoscopic sleeve gastrectomy. |
Valutazione della funzionalità respiratoria dopo somministrazione di
sugammadex e neostigmina per il recupero del blocco n |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• age over 18 years;
• morbid obesity class II (with comorbidities), and class III;
• patients undergoing surgery for laparoscopic bariatric surgery
• presence of neuromuscular monitoring
• presence of moderate neuromuscular blockade (T1-T2 to 10% TOF
ratio) at the time of reversal |
• età superiore ai 18 anni;
• obesità patologica di classe II (con comorbidità) e classe III;
• pazienti candidati a intervento di sleeve gastrectomy per via
XML File Identifier: Q8DyK3aFD7UWw6+tRYGQoZ2tLtU=
Page 14/24
laparoscopica
• presenza di monitoraggio neuromuscolare
• presenza di blocco neuromuscolare moderato (da T1-T2 a 10% TOF
ratio) al momento del reversal |
|
E.4 | Principal exclusion criteria |
• obesity class I and II (in the absence of co-morbidities);
• muscle dysfunction (eg. Myasthenia gravis, muscular dystrophy)
• cardiac disease (eg. prolong QTc syndrome) and / or cardiac ischemia
• renal failure
• liver failure
• allergic reaction to the drugs used in the study
• treatment with oral contraceptives, toremifene, flucloxacillin and
fusidic acid
• known or suspected pregnancy;
•spontaneous recovery at the end of surgery and / or the presence of
profound NMB (no twitches to TOF) at the time of reversal |
• obesità di classe I e II (in assenza di comorbidità);
• disfunzioni muscolari (es. miastenia gravis, distrofia muscolare)
• patologia cardiaca (es. sindrome del QTc lungo) e/o ischemia
cardiaca recente
• insufficienza renale
• insufficienza epatica
• reazione allergica ai farmaci utilizzati nello studio
• trattamento con contraccettivi orali, toremifene, flucloxacillina e
acido fusidico
• gravidanza nota o presunta;
• recupero spontaneo a fine intervento e/o presenza di NMB profondo
(assenza di twitches al TOF) al momento del reversal |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Timing of the reversal
Difference in the time required for complete recovery (TOF ratio ≥0.9)
from moderate or profound neuromuscular block after administration of
sugammadex (TBW group vs. group CBW) during recovery from general
anesthesia at the end of the surgical procedure. |
Timing del reversal
Viene considerata la differenza nel tempo necessario per il completo
recupero (TOF ratio ≥0.9) dal blocco neuromuscolare moderato o
profondo dopo somministrazione di sugammadex e neostigmina nella
fase di risveglio dall'anestesia generale alla fine della procedura
chirurgica. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the surgical procedure |
Alla fine dell'intervento chirurgico |
|
E.5.2 | Secondary end point(s) |
Spirometric evaluation of respiratory function upon awakening from
general anesthesia after reversal of neuromuscular blockade with
sugammadex and neostigmine |
Valutazione spirometrica della funzionalità respiratoria al risveglio
dall'anestesia generale dopo reversal del blocco neuromuscolare con
sugammadex e neostigmina |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For two hours after awakening from general anesthesia |
Per due ore dopo risveglio dall'anestesia generale |
|
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 | 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 | 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
|
After completion of enrollment of total subjects |
Dopo completamento dell'arruolamento di tutti i pazienti |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |