Radboudumc
Nijmegen, 6500HB, Netherlands
NCT Number: NCT05562999
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Nijmegen, 6500HB, Netherlands
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Moderate NMB (TOF 1-2)
Other names: Bridion
Time frame: Postoperative day 1
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Time frame: Postoperative day 30
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Time frame: Postoperative day 1
Serum cytokine IL-6 level
Time frame: Postoperative day 1
Serum cytokine IL-10 level
Time frame: Postoperative day 1
Serum cytokine TNF-a level
Time frame: Postoperative day 1
Ex-vivo IL-6 production capacity upon whole blood Lipopolysaccharide(LPS) stimulation
Time frame: Postoperative day 1
Ex-vivo IL-10 production capacity upon whole blood LPS stimulation
Time frame: During hospital admission up to 3 days postoperative
pain scores with NRS 0 (no pain) to 10 (severe pain)
Time frame: 30 postoperative days
postoperative complications scored by Clavien-Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Time frame: 30 postoperative days
Postoperative infectious complications scored the definitions of the StEP-COMPAC group initiative
Time frame: During hospital admission up to 3 days postoperative
non-cumulative and cumulative opioid use per day in morphine equivalent
Radboud University Medical Center
Other
Deep Versus Moderate Neuromuscular Blockade During Total HIP Replacement Surgery to Improve POstoperative Quality of Recovery and Immune Function: a Randomized Controlled Study
Acronym: HIPPO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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