E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hip osteoarthritis |
Heupartrose |
|
E.1.1.1 | Medical condition in easily understood language |
Arthrosis of the hip |
Heupslijtage |
|
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 |
The overall objective of this study is to investigate the potential immunomodulatory effect of sugammadex as seen in previous ex vivo experiments. Specified, the main objective is to investigate the effect of administration of sugammadex without prior neuromuscular blockade on postoperative innate immune function as reflected by cytokine production capacity of mononuclear cells. |
Het hoofddoel van deze studie is om het potentiele immuunmodulerende effect van sugammadex te onderzoeken, zoals het eerder is gezien in ex vivo experimenten. Meer gespecificeerd is het hoofddoel van de pilot studie om het effect van toediening van sugammadex, zonder voorafgaande neuromusculaire blokkade, te onderzoeken op postoperatieve aangeboren immuun functie. Dit wordt gemeten door cytokine productie capaciteit van mononucleaire cellen te bepalen. |
|
E.2.2 | Secondary objectives of the trial |
To investigate the effect of administration of sugammadex without prior neuromuscular blockade on: - Postoperative innate immune function as reflected by DAMP release - Systemic inflammation as reflected by circulating inflammatory cytokines - Postoperative pain scores and analgesia consumption - Postoperative quality of recovery - Postoperative (infectious) complications |
Het onderzoeken van het effect van toediening van sugammadex zonder voorafgaande neuromusculaire blokkade op: - Postoperatieve immuunfunctie weergegeven als het vrijkomen van DAMPs - Systemsiche inflammatie gemeten door circulerende inflammatoire cytokines - Postoperatieve pijn en analgetica gebruik - Postoperatieve kwaliteit van herstel - Postoperatieve (infectieuze) complicaties |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age of 18 years or older - Scheduled for total hip replacement surgery under neuraxial surgery - Scheduled for primary hip replacement surgery - Informed consent obtained |
- 18 jaar of ouder - Gepland voor totale heup vervanging onder spinale anesthesie - Gepland voor primaire heup vervanging - Informed consent verkregen |
|
E.4 | Principal exclusion criteria |
- Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires - Known or suspected hypersensitivity to sugammadex - Deficiency of vitamin K dependent clotting factors or coagulopathy - Severe renal disease (creatinine clearance <30 ml/min), including patients on dialysis) - Severe liver disease (Child-Pugh Classification C) - Women who are or may be pregnant or currently breastfeeding - Severe vertebral column disorder - Chronic use of psychotropic drugs - Known hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis or severe mitral valve stenosis - Use of immunomodulatory medication |
- Onvoldoende kennis van Nederlandse taal om patiënteninformatie te lezen en vragenlijsten in te vullen - Bekende of verdachte overgevoeligheid voor of sugammadex - Vitamine K-afhankelijke stollingsfactoren deficiëntie of coagulopathie - Ernstig leverfalen (Child-Pugh classificatie C) - Ernstige nierinsufficiëntie (kreatinie klaring <30 ml/min), inclusief dialyse patiënten - Ernstige aandoeningen van de wervelkolom - Vrouwen die zwanger zijn of borstvoeding geven - Chronisch gebruik van psychotropische medicatie of immuunmodulerende medicatie - Bekende hypertrofische obstructieve cardiomyopathie, ernstige aortaklepstenose of ernstige mitralisklepstenose |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Innate immune function as reflected by - Ex vivo cytokine (TNF-α, IL-6, IL-10, IL-1β) production capacity of mononuclear cells upon whole blood lipopolysaccharide (LPS) stimulation.
|
Aangeboren immuunfunctie weergegeven door: - Ex vivo cytokine productie capaciteit (TNF-α, IL-6, IL-10, IL-1β) van mononucleaire cellen op volbloed stimulatie met lipopolysaccharide |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of surgery Postoperative day 1 |
Einde van operatie Postoperatieve dag 1 |
|
E.5.2 | Secondary end point(s) |
- Innate immune function at the end of surgery and postoperative day 1 as reflected by - Circulating inflammatory cytokines (TNF-α, IL-6, IL-10) - DAMP release (HSP70, HMGB1) - Pain scores (NRS 0-10) and total analgesia consumption at the post anesthesia care unit (PACU) and postoperative day 1. - Quality of Recovery score (QoR-40) at postoperative day 1(11). - 30-day postoperative infectious complications scored according to the relevant endpoint of the StEP-COMPAC group initiative - 30-day postoperative complications scored by Clavien Dindo classification. |
- Aangeboren immuunfunctie aan het eind van de operatie en op postoperatieve dag 1 gemeten door: - Circulerende inflammatoire cytokines (TNF-α, IL-6, IL-10) - DAMP afgifte (HSP70, HMGB1) - Pijnscores (NRS 0-10) en totaal analgetica gebruik tot en met postoperatieve dag 1 - Kwaliteit van herstel score (QoR-40) op postoperatieve dag 1 - 30 dagen postoperatieve complicaties gekwalificeerd volgens Clavien-Dindo classificatie - 30 dagen infectieuze complicaties geclassificeerd volgens de StEP-COMPAC groep |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of surgery Post anesthesia care unit Postoperative day 1 Postoperative day 30 |
Einde van de operatie Post anesthesie care unit Postoperatieve dag 1 Postoperatieve dag 30 |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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
|
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | |