Phase 4
Completed N=90
Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery
Neuromuscular Blockade · Surgery · Anesthesia · Spinal Diseases
Source: ClinicalTrials.gov NCT02724111 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Mean Value of Peak Inspiratory Pressure — 18.4; 20.2 cmH2O — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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. Informational only — not medical advice.