E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We will investigate the effect of deep neuromuscular blockade on the abdominal working space. We will include patients undergoing laparoscopic surgery, including laparoscopic donor nephrectomy, laparascopic cholecystectomy and laparoscopic colectomy. |
Wij onderzoeken het effect van diepe spierverslapping op de chirurgische werkruimte tijdens laparoscopische operaties, waaronder laparoscopische donornefrectomie, laparoscopische cholecystectomie en laparoscopische colectomie. |
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E.1.1.1 | Medical condition in easily understood language |
The effect of deep muscle relaxation on the abdominal working space during laparosopy. |
Het effect van diepe spierverslapping tijdens kijkoperaties op de chirurgische werkomstandigheden. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 establish the relationship between the use of deep neuromuscular blockade (NMB) and the abdominal working space (distance from skin to sacral promontory and 3D volume) during laparoscopy with standard pressure pneumoperitoneum. |
Het effect aantonen van diepe spierverslapping op de chirurgische werkruimte (afstand van trocar-promontorium en 3D volume van buikholte) tijdens kijkoperaties met standaard intra-abdominale druk. |
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E.2.2 | Secondary objectives of the trial |
To study the effect of moderate NMB versus no NMB on the abdominal working space (distance from skin to sacral promontory and 3D volume) during laparoscopy with standard pressure pneumoperitoneum. |
We zullen tevens onderzoeken wat het effect is van standaard neuromusculair blok versus geen neuromusculair blok op de chirurgische werkruimte (afstand van trocar-promontorium en 3D volume van buikholte) tijdens kijkoperaties met standaard intra-abdominale druk. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- all adult patients (18 years or older) scheduled for laparoscopic donor nephrectomy, laparoscopic cholecystectomy or laparoscopic colectomy
- obtained informed consent |
- alle volwassen patiënten (vanaf 18 jaar) gepland voor laparoscopische donornefrectomie, laparoscopische cholecystectomie of laparoscopische colectomie
- verkregen informed consent |
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E.4 | Principal exclusion criteria |
• Unable to provide informed consent
• known or suspect allergy to mivacurium, rocuronium or sugammadex
• neuromuscular disease
• indication for rapid sequence induction
• Being unable to undergo MRI due to any reason (e.g. non MRI-compatible implants, epilepsy)
• BMI>30 kg/m2
• ASA-score >2 |
• Niet is staat tot geven van informed consent
• Bekende of vermoede allergie voor mivacurium, rocuronium of sugammadex
• neuromusculaire stoornis
• indicatie rapid sequence inductie
• Contraindicatie voor MRI (bijvoorbeeld vanwege epilepsie of MRI incompatibele implantaten)
• BMI>30 kg/m2
• ASA-score >2 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The abdominal working space space measured by MRI: Skin - sacral promontory distance |
Het chirurgische werkveld gemeten dmv MRI: afstand van trocar tot promontorium |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Following induction of general anesthesia and creation of pneumoperitoneum, each patiënt will undergo a MRI scan in 3 phases (total duration 30 minutes)
- phase 1: no NMB (first scan)
- phase 2: moderate NMB (second scan)
- phase 3: deep NMB (third scan)
After completion of the third scan the laparoscopic procedure will be continued. |
Na inductie van de algehele anesthesie en creëren van het pneumoperitoneum (12 mmHg), zal elke patiënt een MRI scan ondergaan in 3 fasen (totale duur van 30 minuten)
- fase 1 : geen NMB (eerste scan)
- fase 2: standaard NMB (tweede scan)
- fase 3: diep NMB (3e scan)
Na de 3e scan fase zal de laparoscopische procedure worden gecontinueerd volgens standaard protocol. |
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E.5.2 | Secondary end point(s) |
The abdominal working space space measured by MRI: 3D volume of the abdominal cavity |
Het chirurgische werkveld gemeten dmv MRI: 3D volume van de buikholte |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Following introduction of general anesthesia and creation of pneumoperitoneum, each patiënt will undergo a MRI scan in 3 phases (total duration 30 minutes)
- phase 1: no NMB (first scan)
- phase 2: moderate NMB (second scan)
- phase 3: deep NMB (third scan)
After completion of the third scan the laparoscopic procedure will be continued. |
Na inductie van de algehele anesthesie en creëren van het pneumoperitoneum (12 mmHg), zal elke patiënt een MRI scan ondergaan in 3 fasen (totale duur van 30 minuten)
- fase 1 : geen NMB (eerste scan)
- fase 2: standaard NMB (tweede scan)
- fase 3: diep NMB (3e scan)
Na de 3e scan fase zal de laparoscopische procedure worden gecontinueerd volgens standaard protocol. |
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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 | 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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
prospectieve cohort studie, 3 fases in elke patiënt (geen, standaard en diep NMB) |
prospective cohort study, 3 phases in each patiënt (no, moderate and deep NMB) |
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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 |
prospectieve cohort studie, 3 fases in elke patiënt (geen, standaard en diep NMB) |
prospective cohort study, 3 phases in each patiënt (no, moderate and deep NMB) |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 |
laatste bezoek (operatie), laatste patiënt. |
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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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |