Phase 4
N=100
Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile
Postoperative Respiratory Condition
Bottom Line
View on ClinicalTrials.gov: NCT02243943 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Mean Lowest Saturation — 96.8; 93.3 percentage of oxygen saturation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex (Drug); Neostigmine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Leiden University Medical Center
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Lowest Saturation |
96.8; 93.3 | — |
| SECONDARY Pain |
3.0; 3.2 | — |
| SECONDARY Sedation |
1.4; 1.4 | — |
Summary
Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.
Eligibility Criteria
Inclusion Criteria
- Age 18 years
- - BMI < 35
- -ASA class I- III
- -Patients scheduled for surgery requiring general anesthesia with the use of NMBA's
- Patients with ability to give oral and written informed consent
Exclusion Criteria
- Failure to meet the inclusion 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
- -Contraindications for the use of neostigmine
- Intestinal obstruction,
- COPD GOLD 4
- -Abnormal heart rhythm (eg. bradycardia: < 40/min);
- -Surgery requiring neuraxial anesthesia / analgesia
- -Preoperative cognitive dysfunction or mental disabilities
- -Preexistent significant pulmonary disease with preoperative SpO2 < 90%
- -Preoperative ICU treatment / intubation (ICU patient);
- -Need for postoperative ICU treatment or ventilation;
Data sourced from ClinicalTrials.gov (NCT02243943). 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.