E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
oesophageal carcinoma |
Slokdarm carcinoom |
|
E.1.1.1 | Medical condition in easily understood language |
cancer of the oesophagus |
Slokdarm kanker |
|
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 evaluate the use of deep muscle relaxation versus on indication only on surgical and anesthesia conditions in patients for endoscopic esophageal resection. |
het evalueren van diepe spierverslapping versus op indicatie gebruik op chirurgische en anesthesiologische condities in patienten die een scopische slokdarm resectie krijgen |
|
E.2.2 | Secondary objectives of the trial |
to evaluate the (hypothetical) dose of sugammadex needed in both groups in an economical perspective and to compare the intra-operative cardiac and respiratory incidents and post-operative complication rate of both groups. |
Secundaire doel is het evalueren van de dosis sugammadex nodig in beide groepen en dit te plaatsen in een economisch perspectief en het vergelijken van intraoperatieve cardiale en respiratoire events en post-operatieve complicatie incidentie. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients > 18 years to undergo a thoracolaparoscopic esophageal resection.I |
Alle patienten ouder dan 18 jaar, die een thoraco-laparoscopische oesophagus cardia resectie moeten ondergaan |
|
E.4 | Principal exclusion criteria |
aged < 18 or pregnancy known allergies for aminosteroid-type muscle relaxants or sugammadex. Severe kidney dysfunction (GFR < 30), patients on dialysis.
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Leeftijd < 18. Bekende allergieen voor aminosteroide neuromuscualire antagonsiten of Sugammadex. Ernstige nierfunctiestoornissen met GFR < 30, patienten met nierdialyse. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rating of surgical conditions (SRS) during the abdominal phase of the operation. |
Chirurgische condities tijdens de abdominale fase van de operatie |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Every 30 minutes during surgery |
Elke 30 minuten tijdens de operatie |
|
E.5.2 | Secondary end point(s) |
- Rating of SRS during thoracic phase of the operation. Number of on demand boluses infused, indication of on demand bolus administration, - Rating of anesthesia conditions including: peak and mean respiratory pressure, incidence peak insufflation pressure >35 mmHg. Depth of NBM at the end of surgery. Time until spontaneous breathing, time until extubation. Peroperative cardiac and respiratory incidents. - Cost analysis: amount of rocuronium used (mg); Dose of sugammadex needed (mg), time to reversal, duration of surgery, hypothetical need for need for post-operative ventilation (%). |
- Chirurgische condities tijdens de scopische fase van de operatie - Hoeveelheid rescue bolus toediening en de indicatie daarvan. - Anesthesiologische condities, zoals beademingsdrukken, hoeveelheid restverslapping, tijd tot spontane ademhaling, tijd tot extubatie. Peroperatieve cardiale en respiratoire incidenten. - kosten analyse: Hoeveelheid rocuronium, sugammadex nodig. Tijd tot reversal, duur chirurgie, hypothetische behoefte tot post-operatieve beademing. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For surgical conditions, every 30 minutes, for anesthesiologisc conditions and resucue medication, continuously. For costanalysis at the end of surgical procedure |
voor chirurgische condities, elke 30 min. Voor anesthesiologische condities en rescue medicatie continue. De kostenanalyse aan het einde van de operatie. |
|
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 | No |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
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
|
No stopping rules apply. 60 patients will be included. Patients can be replaced if less than 3 surgical ratings (due to early termination of the surgical procedure) |
Er zijn geen stopping rules. Zestig patienten zullen geincludeerd worden. Patienten kunnen vervangen worden als er minder dan 3 surgical rating scores mogelijk zijn omdat de operatie niet afgemaakt kan worden. |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |