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…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative 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.
Secondary outcome
- 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).
- Innate immune function prior to incision
- 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.
Background summary
Infections are the number one complication after surgery. Moreover it is known
that surgery itself, combined with anaesthesia, has a negative impact on
immunity through several mechanisms. Seen the potentially devestating result of
postoperative infectious complications, more research is aimed at therapeutic
strategies that positively influence the postoperative immune dysregulation.
Our group aimed at reducing surgical stress by use of a deep neuromuscular
blockade. In this search we found evidence that sugammadex, used to antogonize
neuromuscular blockade, may have an immunomodulatory effect itself. Ex vivo
analysis showed that sugammadex counteracted the immunosuppressive effect of
rocuronium, but even in absence of rocuronium it had a positive effect on
cytokine production capacity (see pages 9-11 of the protocol for the exact
data).
These results raise the question wether sugammadex truly has an
immunomodulatory potention. Therefore, we now propose a pilot study to
investigate this.
Study objective
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.
Study design
A randomized blinded pilot study
Intervention
The experimental group will receive sugammadex (8mg/kg) at the end of surgery,
the control group will receive placebo (NaCl 0.9%) at the same moment.
Study burden and risks
Sugammadex is a registered and a safe drug which will be used in a dosage
within normal therapeutical range. A specific study design with only sugammadex
administration without prior neuromuscular blockade is chosen to evaluate the
effect of solely sugammadex. Sugammadex administration without prior
neuromuscular blockade is not thought to add additional risk. Any possible risk
factors or interactions as mentioned in the Summary of Product Characteristics
are covered by exclusion criteria in order to fully eliminate risk of
participation. The burden of participation for patients consist mainly of
withdrawal of extra blood samples. Blood samples will be obtained prior to
surgery, twice during surgery and one day postoperative. Blood samples will be
combined with routine lab assessment as much as possible.
Geert Grooteplein zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
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
Exclusion criteria
- Insufficient control of the Dutch language to read the patient information
and to fill out de questionnaires
- Mentally incapcitated patients
- 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
- Women of childbearing potential who don't use adequate method of contraception
- Severe vertebral column disorder
- Chronic use of psychotropic drugs
- Known hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis
or severe mitral valve stenosis
- Chronic use of NSAID's, steroids or immunosuppressive drugs
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-003325-22-NL |
| CCMO | NL82808.091.22 |