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

Radboud University Medical Center

Status and phase

Completed

Phase 4

Conditions

Postoperative Complications

Quality of Life

Innate Inflammatory Response

Neuromuscular Blockade

Treatments

Drug: Rocuronium Bromide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05562999

NL81931.091.22

Details and patient eligibility

About

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.

Full 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

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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