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Completed

NCT Number: NCT05562999

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Radboudumc

Nijmegen, 6500HB, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium bromide

Drug

Moderate NMB (TOF 1-2)

Other names: Bridion

Primary outcomes

  1. Quality of Recovery 40 (QoR-40) questionnaire score

    Time frame: Postoperative day 1

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

Secondary outcomes

  1. Quality of Recovery 40 (QoR-40) questionnaire score

    Time frame: Postoperative day 30

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

  2. Immune function represented by serum cytokine

    Time frame: Postoperative day 1

    Serum cytokine IL-6 level

  3. Immune function represented by IL-10

    Time frame: Postoperative day 1

    Serum cytokine IL-10 level

  4. Immune function represented by TNF-a

    Time frame: Postoperative day 1

    Serum cytokine TNF-a level

  5. Immune function represented by ex-vivo IL-6 production capacity

    Time frame: Postoperative day 1

    Ex-vivo IL-6 production capacity upon whole blood Lipopolysaccharide(LPS) stimulation

  6. Immune function represented by ex-vivo IL-10 production capacity

    Time frame: Postoperative day 1

    Ex-vivo IL-10 production capacity upon whole blood LPS stimulation

  7. Pain score by numeric pain rating (NRS) scale

    Time frame: During hospital admission up to 3 days postoperative

    pain scores with NRS 0 (no pain) to 10 (severe pain)

  8. Postoperative complications

    Time frame: 30 postoperative days

    postoperative complications scored by Clavien-Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)

  9. Infectious postoperative complications

    Time frame: 30 postoperative days

    Postoperative infectious complications scored the definitions of the StEP-COMPAC group initiative

  10. Analgesia consumption

    Time frame: During hospital admission up to 3 days postoperative

    non-cumulative and cumulative opioid use per day in morphine equivalent

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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