Deep Versus Moderate Neuromuscular Blockade During Total HIP Replacement Surgery to Improve POstoperative Quality of Recovery and Immune Function: a Randomized Controlled Study

NL81931.091.22

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.

2022-11-18

2024-05-01

2024-05-01

Recruiting

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-11-14