Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex

Neuromuscular Blockade Clinical Trial

Official title:

Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932254
• Other study ID #: PAGF02MG
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2016
• Last updated: February 8, 2018
• Start date: October 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2018
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Magnesium Sulfate
After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).
• Saline
After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).

Locations

Country	Name	City	State
Brazil	Hospital Federal de Bonsucesso	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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).	1 hour after the end of surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluate postoperative pain	Use of visual analogue pain scale (0-10) questionnaire	72 hours