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

NCT05562999 | Completed Phase 4

• 1 other identifier: NL81931.091.22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery 40 (QoR-40) questionnaire score

  40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)

  Postoperative day 1

Secondary Outcomes (10)

• Quality of Recovery 40 (QoR-40) questionnaire score

  Postoperative day 30

• Immune function represented by serum cytokine

  Postoperative day 1

• Immune function represented by IL-10

  Postoperative day 1

• Immune function represented by TNF-a

  Postoperative day 1

• Immune function represented by ex-vivo IL-6 production capacity

  Postoperative day 1

Study Arms (2)

Deep neuromuscular blockade

EXPERIMENTAL

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

Drug: Rocuronium Bromide

Moderate neuromuscular blockade

ACTIVE COMPARATOR

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

Drug: Rocuronium Bromide

Interventions

Rocuronium Bromide DRUG

Moderate NMB (TOF 1-2)

Also known as: Bridion

Moderate neuromuscular blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Radboudumc

Nijmegen, 6500HB, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 39773137 DERIVED

• 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.

  PMID: 37640469 DERIVED

MeSH Terms

Conditions

Inflammation; Postoperative Complications

Interventions

Rocuronium; Sugammadex

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: November 18, 2022
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)