Deep versus moderate neuromuscular blockade during total hip replacement surgery to improve postoperative quality of recovery and immune function: a randomized controlled study

Osteoarthritis is the most common joint disorders affecting elderly patients
worldwide and the rate of hip surgery has increased dramatically with the
growing elderly population. Neuromuscular blockade agents (NMB) may enable
surgeons to optimize exposure during hip surgery. With an increasing depth of
NMB, manipulation of muscles and adjunctive tissues will be easier, therefore
reducing damage to muscles and adjunct tissues. Accumulating evidence exists
that the use of deep NMB in laparoscopic surgery is associated with a better
quality of recovery and lower pain scores. However, whether this accounts for
open surgery is still unknown.
Moreover, surgery is associated with postoperative immune suppression. Surgical
stress and damage cause the release of Danger Associated Molecular Patterns
(DAMPs). After trauma and sepsis, the release of DAMPs is associated with
immune paralysis and a higher susceptibility to infectious complications.
Previous research indicates that DAMPS are the origin of postoperative immune
suppression. The use of deep NMB in hip surgery may reduce surgical damage and
thereby lead to a better quality of recovery and secondarily a better
preservation of immune cell function.

The main objective of this study is to assess the potential effect of deep
neuromuscular blockade on the quality of recovery after total hip replacement
surgery under general anesthesia.
Secondary aims are to establish the relationship between the use of deep
neuromuscular blockade versus moderate deep neuromuscular blockade and innate
immune function and establish the relationship with postoperative pain scores
and the incidence infectious complications after total hip replacement surgery.

A monocentre, blinded, randomized controlled clinical trial

Patients will be randomized between a deep neuromuscular blockade group
(Post-tetanic count 1-2) and moderate neuromuscular blockade groep
(Train-of-four count 1-2)

A deep NMB is achieved by higher doses of rocuronium which are within normal
therapeutic range used in clinical practice, and is safe to use. Depth of NMB
will be monitored throughout the whole surgery. At the end of surgery, the
effects of rocuronium will be antagonized by sugammadex to avoid residual
paralysis.
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 is
mainly associated with the questionnaires one day and 30 days postoperative.
Questionnaires at postoperative day 1 and 40 approximately take 10-15 minutes.
Blood samples will be combined with routine laboratory assessment when
possible. Assessment of pain scores, opioid consumption and complications are
part of the normal treatment.