Clinical trial NCT05562999: Impact of Deep Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function
Official title: Deep Versus Moderate Neuromuscular Blockade During Total HIP Replacement Surgery to Improve POstoperative Quality of Recovery and Immune Function: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Innate Inflammatory Response
Quality of Life
Postoperative Complications
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Monocenter randomized controlled trial to compare the effect of deep neuromuscular blockade (NMB) versus moderate NMB during total hip replacement surgery on postoperative quality of recovery and innate immune function.

Detailed description: Rationale: 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 may 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.

In addition, 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.

Primary objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) versus moderate NMB and the quality of recovery after total hip replacement surgery (THR) Secondary objective: To establish the relationship between the use of deep NMB versus moderate NMB and innate immune function after THR surgery

Study design: A monocenter, blinded, randomized controlled clinical trial

Study population: adults who are scheduled for primary or secondary hip replacement surgery under general anaesthesia.

Intervention: Patients will be randomized between a deep NMB (post tetanic count (PTC) 1-2) and moderate NMB (Train-of-four (TOF) 1-2)

Primary endpoint: Quality of Recovery score (QoR-40) at postoperative day 1.

Secondary endpoints: postoperative innate immune function, QoR-40 at postoperative day 30, 30-day postoperative (infectious) complications, postoperative pain scores and opioid consumption

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* Scheduled for total hip replacement surgery under general anaesthesia
* Informed consent obtained

Exclusion Criteria:

* Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
* Known or suspected hypersensitivity to rocuronium or 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)
* Known or suspected neuromuscular disorders impairing neuromuscular function
* Women who are or may be pregnant or currently breastfeeding
* Chronic use of psychotropic drugs
* Use of immunomodulatory medication

Primary outcomes:
measure: Quality of Recovery 40 (QoR-40) questionnaire score
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Quality of Recovery 40 (QoR-40) questionnaire score
timeFrame: Postoperative day 30
measure: Immune function represented by serum cytokine
timeFrame: Postoperative day 1
measure: Immune function represented by IL-10
timeFrame: Postoperative day 1
measure: Immune function represented by TNF-a
timeFrame: Postoperative day 1
measure: Immune function represented by ex-vivo IL-6 production capacity
timeFrame: Postoperative day 1
measure: Immune function represented by ex-vivo IL-10 production capacity
timeFrame: Postoperative day 1
measure: Pain score by numeric pain rating (NRS) scale
timeFrame: During hospital admission up to 3 days postoperative
measure: Postoperative complications
timeFrame: 30 postoperative days
measure: Infectious postoperative complications
timeFrame: 30 postoperative days
measure: Analgesia consumption
timeFrame: During hospital admission up to 3 days postoperative
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
References: