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

Quality of Life Clinical Trial

— HIPPO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562999
• Other study ID #: NL81931.091.22
• Status: Recruiting
• Phase: Phase 4
• Start date: November 18, 2022
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Neuromuscular Blockade
• Postoperative Complications
• Quality of Life

Intervention

Drug:
• Rocuronium Bromide
Moderate NMB (TOF 1-2)
• Rocuronium Bromide
Deep NMB (PTC 1-2)

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 30
Secondary	Immune function represented by serum cytokine	Serum cytokine IL-6 level	Postoperative day 1
Secondary	Immune function represented by IL-10	Serum cytokine IL-10 level	Postoperative day 1
Secondary	Immune function represented by TNF-a	Serum cytokine TNF-a level	Postoperative day 1
Secondary	Immune function represented by ex-vivo IL-6 production capacity	Ex-vivo IL-6 production capacity upon whole blood Lipopolysaccharide(LPS) stimulation	Postoperative day 1
Secondary	Immune function represented by ex-vivo IL-10 production capacity	Ex-vivo IL-10 production capacity upon whole blood LPS stimulation	Postoperative day 1
Secondary	Pain score by numeric pain rating (NRS) scale	pain scores with NRS 0 (no pain) to 10 (severe pain)	During hospital admission up to 3 days postoperative
Secondary	Postoperative complications	postoperative complications scored by Clavien-Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)	30 postoperative days
Secondary	Infectious postoperative complications	Postoperative infectious complications scored the definitions of the StEP-COMPAC group initiative	30 postoperative days
Secondary	Analgesia consumption	non-cumulative and cumulative opioid use per day in morphine equivalent	During hospital admission up to 3 days postoperative