Phase 4
N=116
Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
Arthropathy of Hip
Bottom Line
View on ClinicalTrials.gov: NCT03219294 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Surgical Conditions — 1; 2; 11; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vecuronium 0.1 mg/kg (Drug); Vecuronium 0.2mg/kg (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Craig Curry
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Conditions |
1; 2; 11; 10; 30; 29 | — |
| SECONDARY Duration of Surgery |
32.6; 33.8 | — |
Summary
During many surgeries, increased muscle tension makes it harder for the surgeon to expose the site of surgery and work within the incision. Neuromuscular blockade (NMB) drugs such as Vecuronium bind to neurotransmitter (acetyl choline) receptors at the neuromuscular junction, blocking their action and producing muscle relaxation. This muscle relaxation allows easier retraction of muscle tissues and manipulation of structures in the wound. Improved surgical conditions are likely to result in improved patient outcomes. While increased depths of NMB have been shown to optimize surgical conditions during intra-abdominal and retroperitoneal procedures, the impact of NMB depth has not been reported for orthopedic surgeries.1 To address this, we propose to study the effect of NMB depth on surgical conditions during total hip replacement (THR).
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) Physical status 1-3
- age 50-75
- English speaking
- able to provide informed consent
- BMI equal to less than 30
- non-emergent THR by anterolateral minimally invasive non-cemented total hip arthroplasty
Exclusion Criteria
- Revision surgery
- Bilateral THR
- ASA 4+
- age less than 50 or greater than 75
- BMI greater than 30
- unable to provide informed consent
- women taking oral contraceptives (Sugammadex used for reversal interferes with their efficacy
- contraindications to general inhalation anesthesia (such as malignant hyperthermia)
- contraindications to NMB (known allergy to NMB)
- chronic kidney disease
Data sourced from ClinicalTrials.gov (NCT03219294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.