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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate | Active Comparator |
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| Saline Solution | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution). |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio . | 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. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Record the possible serious respiratory events in the post-anesthetic recovery room | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulo A Germano Filho, MSc | Hospital Federal de Bonsucesso | Principal Investigator |
| Ismar L Cavalcanti, PhD | Universidade Federal Fluminense | Study Director |
| Nubia V Figueiredo, PhD | Universidade Federal do Rio de Janeiro | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Federal de Bonsucesso | Rio de Janeiro | Rio de Janeiro | 22271042 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25582520 | Background | Unterbuchner C, Ziegleder R, Graf B, Metterlein T. Magnesium-induced recurarisation after reversal of rocuronium-induced neuromuscular block with sugammadex. Acta Anaesthesiol Scand. 2015 Apr;59(4):536-40. doi: 10.1111/aas.12461. Epub 2015 Jan 13. | |
| 22183158 | Result | Hans GA, Bosenge B, Bonhomme VL, Brichant JF, Venneman IM, Hans PC. Intravenous magnesium re-establishes neuromuscular block after spontaneous recovery from an intubating dose of rocuronium: a randomised controlled trial. Eur J Anaesthesiol. 2012 Feb;29(2):95-9. doi: 10.1097/EJA.0b013e32834e13a6. |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Saline | Drug | After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution). |
|
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| 1 hour after the end of surgery |
| Evaluate the occurrence of any residual neuromuscular block in the post anesthetic recovery room | 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. | 1 hour after the end of surgery |
| Record the evolution of the height of the first response (T1) | 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. | 1 hour after the end of surgery |
| Record the possible occurrence of severe respiratory complications every 24 hours | 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). | 72 hours max |
| Evaluate postoperative pain | Use of visual analogue pain scale (0-10) questionnaire | 72 hours |
| 25962433 | Result | Carron M, Ori C. Magnesium-induced recurarisation after reversal of rocuronium-induced neuromuscular block with sugammadex. Findings vs. speculation. Acta Anaesthesiol Scand. 2015 Aug;59(7):946-7. doi: 10.1111/aas.12551. Epub 2015 May 12. No abstract available. |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |