Postoperative Respiratory Condition
Conditions
Keywords
Neuromuscular block, neuromuscular reversal, postoperative conditions, respiratory failure
Brief 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.
Interventions
DRUGSugammadex
DRUGNeostigmine
Sponsors
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Lowest Saturation | 45 minutes post surgery | Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 45 minutes post surgery | using the 1-10 numeric rating scale |
| Sedation | 45 minutes post surgery | using the Leiden observer alertness score (1 alert - 5 sedated) |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sugammadex Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
Sugammadex | 50 |
| Neostigmine subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
Neostigmine | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Sugammadex | Neostigmine | Total |
|---|---|---|---|
| Age, Continuous | 55 years of age | 55 years of age | 55 years of age |
| Gender Female | 27 Participants | 24 Participants | 51 Participants |
| Gender Male | 23 Participants | 26 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Mean Lowest Saturation
Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery
Time frame: 45 minutes post surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sugammadex | Mean Lowest Saturation | 96.8 percentage of oxygen saturation |
| Neostigmine | Mean Lowest Saturation | 93.3 percentage of oxygen saturation |
Secondary
Pain
using the 1-10 numeric rating scale
Time frame: 45 minutes post surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sugammadex | Pain | 3.0 Numeric rating scale. 1(low)-10(maximum) |
| Neostigmine | Pain | 3.2 Numeric rating scale. 1(low)-10(maximum) |
Secondary
Sedation
using the Leiden observer alertness score (1 alert - 5 sedated)
Time frame: 45 minutes post surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sugammadex | Sedation | 1.4 sedation scale (1 alert - 5 sedated) |
| Neostigmine | Sedation | 1.4 sedation scale (1 alert - 5 sedated) |