Lumbar Spine Disease
Conditions
Brief summary
The effect of deep neuromuscular blockade (NMB) during spine surgery reduced postoperative pain and bleeding in recent studies. Therefore by reducing these two factors, which were the contributing factors for postoperative delirium, deep NMB is expected to reduce the postoperative delirium. This study was designed to determine whether the deep NMB lowered the incidence of delirium after lumbar surgery.
Interventions
DRUGRocuronium for deep NMB
Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.
DRUGRocuronium for moderate NMB
Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.
Sponsors
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 70 and more; * Scheduled for an elective lumbar spine surgery; * ASA physical status 1-3
Exclusion criteria
* Diagnosed neuromuscular disorder; * Contraindications to the study drug, e. g. known allergy or hypersensitivity, hypotension, bradycardia, higher grade atrioventricular block; * Patient with pre-existing cognitive impairment or dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium by CAM-ICU | from just after surgery at the PACU to post-operative 5 days | Occurrence of delirium assessed by CAM-ICU during the post-operative 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intramuscular pressure | intraoperative | Intramuscular pressure at the para-spinal muscles |
| Peak inspiratory airway pressure | intraoperative | Peak inspiratory airway pressure (mmHg) |
Countries
South Korea
Outcome results
None listed