Impact of Deep Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function

NCT ID: NCT05562999

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-18
• Study Completion Date: 2024-08-29

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

Conditions

Neuromuscular Blockade; Innate Inflammatory Response; Quality of Life; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Deep neuromuscular blockade

Participant will receive deep neuromuscular blockade (PTC 1-2)

Group Type: EXPERIMENTAL

Rocuronium Bromide

Intervention Type: DRUG

Deep NMB (PTC 1-2)

Moderate neuromuscular blockade

Participant will receive moderate neuromuscular blockade (TOF 1-2)

Group Type: ACTIVE_COMPARATOR

Rocuronium Bromide

Intervention Type: DRUG

Moderate NMB (TOF 1-2)

Interventions

Rocuronium Bromide

Moderate NMB (TOF 1-2)

Intervention Type: DRUG

Rocuronium Bromide

Deep NMB (PTC 1-2)

Intervention Type: DRUG

Other Intervention Names

Bridion; Bridion

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboudumc

Nijmegen, , Netherlands

Countries

Netherlands

References

Jacobs LMC, Bijkerk V, van Eijk LT, Joosten LAB, Keijzer C, Visser J, Warle MC. The effect of general versus spinal anesthesia on perioperative innate immune function in patients undergoing total hip arthroplasty. BMC Anesthesiol. 2025 Jan 7;25(1):10. doi: 10.1186/s12871-024-02883-1.

Reference Type: DERIVED

PMID: 39773137 (View on PubMed)

Bijkerk V, Visser J, Jacobs LMC, Keijzer C, Warle MC. Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study. BMJ Open. 2023 Aug 28;13(8):e073537. doi: 10.1136/bmjopen-2023-073537.

Reference Type: DERIVED

PMID: 37640469 (View on PubMed)

Other Identifiers

NL81931.091.22

Identifier Type: -

Identifier Source: org_study_id