Phase 4
N=98
Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.
Surgical Conditions
Bottom Line
View on ClinicalTrials.gov: NCT03170661 ↗Enrolled (actual)
98
Serious AEs
7.1%
Results posted
Feb 2021
Primary outcome: Primary: Leiden Surgical Rating Scale — 4.8; 4.8 score on a scale — p=0.94
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Deep neuromuscular block (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Leiden University Medical Center
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leiden Surgical Rating Scale |
4.8; 4.8 | 0.94 |
| SECONDARY Postoperative Measurements and Outcomes; Pain Scores |
2.9; 3.2 | — |
| SECONDARY Intraoperative Hemodynamic Conditions |
84; 85 | — |
| SECONDARY Postoperative Measurements and Outcomes; Sedation Levels |
0.9; 1.0 | — |
| SECONDARY Postoperative Measurements and Outcomes; Saturation |
98; 98 | — |
| SECONDARY Intraoperative Nociception Level |
11; 13 | — |
Summary
A deep neuromuscular block (NMB) is often associated with improved surgical conditions especially in laparoscopic surgery. We previously showed that deep NMB is superior to a moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia maintenance.
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy;
- American Society of Anesthesiologists (ASA) class I-III
- > 18 years of age;
- Ability to give oral and written informed consent.
Exclusion Criteria
- Known or suspected neuromuscular disorders impairing neuromuscular function;
- Allergies to muscle relaxants, anesthetics or narcotics;
- A (family) history of malignant hyperthermia;
- Women who are or may be pregnant or are currently breast feeding;
- Renal insufficiency, as defined by glomerular filtration rate 35 kg/m2
Data sourced from ClinicalTrials.gov (NCT03170661). 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.