Neuromuscular Blockade
Conditions
Keywords
Physiological Effects of Drugs, Rocuronium, Sugammadex sodium, Magnesium, Neuromuscular block, antagonism
Brief summary
The aim of this study is to evaluate the treatment effect of magnesium sulfate on the T4 / T1 ratio after reversal with sugammadex deep or moderate neuromuscular blockade induced by rocuronium.
Detailed description
Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma, antinociceptive action and neuroprotective effects. However, its use is limited because magnesium potentiates non-depolarizing neuromuscular blocking agents. Primary outcome: evaluating the effect of treatment with magnesium sulfate the T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium. Secondary outcome: evaluate the occurrence of severe respiratory events, the incidence of residual neuromuscular block in the post-anesthetic recovery room, evolution of T1 high, and postoperative pain.
Interventions
DRUGMagnesium Sulfate
After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).
DRUGSaline
After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).
Sponsors
Universidade Federal do Rio de Janeiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status 1 or 2 * weight BMI 18.5-24.9 * otorhinolaryngological surgeries
Exclusion criteria
* refusal to participate in the study; * pregnancy or suspected pregnancy; * neuromuscular diseases, renal or hepatic impairment; * hepatic dysfunction; * story or predictors of difficult airway; * hypermagnesemia (Mg\> 2.5 mEq / L); * hypomagnesemia (Mg \<1.7 mEq / L); * furosemide, aminoglycosides, aminophylline azathioprine; cyclophosphamide, anti-inflammatory and magnesium; * allergy to drugs used in the study; * participants from other clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio . | 3 hours | The T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium.Clinical tests and contraction of the adductor pollicis muscle in response to ulnar nerve train-of-four (TOF) stimulation was acceleromyographically quantified using a TOF-Watch SX. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Record the possible serious respiratory events in the post-anesthetic recovery room | 1 hour after the end of surgery | Obstruction of the upper airway that requires intervention; mild to moderate hypoxemia - lower saturation between 90% -93%, with no improvement after request to deep breathing or tactile stimulation; severe hypoxemia - saturation less than 90%, with no improvement after request to deep breathing or tactile stimulation; signs of increased work of breathing - more than 20 breaths per minute and use of accessory muscles; inability to breathe deeply when requested; via musculature of signs of weakness air higher, as speech disability; reintubation in the post anesthetic recovery room; clinical evidence or suspicion of bronchial aspiration after extubation (gastric contents oropharyngeal or tracheal tube accompanied by hypoxemia). |
| Evaluate the occurrence of any residual neuromuscular block in the post anesthetic recovery room | 1 hour after the end of surgery | Clinical tests and contraction of the adductor pollicis muscle in response to ulnar nerve train-of-four (TOF) stimulation was acceleromyographically quantified using a TOF-Watch SX. |
| Record the evolution of the height of the first response (T1) | 1 hour after the end of surgery | Clinical tests and contraction of the adductor pollicis muscle in response to ulnar nerve train-of-four (TOF) stimulation was acceleromyographically quantified using a TOF-Watch SX. |
| Record the possible occurrence of severe respiratory complications every 24 hours | 72 hours max | Obstruction of the upper airway that requires intervention; mild to moderate hypoxemia - lower saturation between 90% -93%, with no improvement after request to deep breathing or tactile stimulation; severe hypoxemia - saturation less than 90%, with no improvement after request to deep breathing or tactile stimulation; signs of increased work of breathing - more than 20 breaths per minute and use of accessory muscles; inability to breathe deeply when requested; via musculature of signs of weakness air higher, as speech disability; reintubation in the post anesthetic recovery room; clinical evidence or suspicion of bronchial aspiration after extubation (gastric contents oropharyngeal or tracheal tube accompanied by hypoxemia). |
| Evaluate postoperative pain | 72 hours | Use of visual analogue pain scale (0-10) questionnaire |
Countries
Brazil
Outcome results
None listed