Phase 4
N=90
Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery
Neuromuscular Blockade · Surgery · Anesthesia · Spinal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02724111 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Mean Value of Peak Inspiratory Pressure — 18.4; 20.2 cmH2O — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- sufficient dose of rocuronium (Drug); sugammadex 10 min after position change (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Korea University Guro Hospital
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Value of Peak Inspiratory Pressure |
18.4; 20.2 | <0.001 sig |
| SECONDARY Mean Value of Pressure of Back Muscle Retractor |
81.2; 100 | <0.001 sig |
| SECONDARY Overall Satisfaction of Surgeons for the Surgical Condition |
8; 3.1 | <0.001 sig |
| SECONDARY The Muscle Tone |
1.3; 2.5 | <0.001 sig |
| SECONDARY The Number of Body Movements |
0; 2 | <0.001 sig |
| SECONDARY The Degree of Bleeding |
1.8; 3.3 | <0.001 sig |
| SECONDARY Recovery Time (Time to Reach Sedation Score 5 at Postanesthesia Care Unit (PACU). |
10.5; 17 | 0.06 |
| SECONDARY Adverse Events : The Postoperative Nausea and Vomiting Occurrence in Subject |
11; 8 | 0.202 |
Summary
The investigators aim to investigate operating conditions, postoperative recovery and overall satisfaction of surgeons between deep neuromuscular blockade (NMB) group and restricted NMB group during spinal surgery under general anesthesia. The investigators hypothesize that this study can present good surgical conditions, postoperative recovery outcomes and overall satisfaction of surgeons in deep NMB group, thereby proving the advantages of deep NMB as well as flaws of restricted NMB in spine surgeries.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) physical status I-II adult patients scheduled for elective spinal (cervical or lumbar) surgery under general anesthesia
Exclusion Criteria
- Pregnancy
- Present medication known to interfere with neuromuscular blockade
- Diseases affecting neuromuscular transmission
- History of hypersensitivity on rocuronium or sugammadex
- Emergent spinal surgery
- Spinal surgeries which have lesions more than 3 spinal levels
- Spinal surgeries which have duration less than 1 hour
- Spinal surgeries which are not performed under prone position
- Spinal surgeries which are not performed under total intravenous anesthesia (TIVA).
- Patients who will have hemodynamic instability (mean blood pressure increase or fall of > 30% from baseline lasting for more than 5 min) during surgery
- Patients who will have blood loss > 1 L during surgery
- MEP monitored spinal surgeries
Data sourced from ClinicalTrials.gov (NCT02724111). 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.