Clinical trial NCT02932254: Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex
Official title: Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Keywords: Physiological Effects of Drugs
Rocuronium
Sugammadex sodium
Magnesium
Neuromuscular block, antagonism
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio .
timeFrame: 3 hours
Secondary outcomes:
measure: Record the possible serious respiratory events in the post-anesthetic recovery room
timeFrame: 1 hour after the end of surgery
measure: Evaluate the occurrence of any residual neuromuscular block in the post anesthetic recovery room
timeFrame: 1 hour after the end of surgery
measure: Record the evolution of the height of the first response (T1)
timeFrame: 1 hour after the end of surgery
measure: Record the possible occurrence of severe respiratory complications every 24 hours
timeFrame: 72 hours max
measure: Evaluate postoperative pain
timeFrame: 72 hours
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Federal de Bonsucesso
state: RJ
Study officials:
affiliation: Hospital Federal de Bonsucesso
name: Paulo A Germano Filho, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal Fluminense
name: Ismar L Cavalcanti, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal do Rio de Janeiro
name: Nubia V Figueiredo, PhD
role: STUDY_DIRECTOR
References:
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.
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):95-9. doi: 10.1097/EJA.0b013e32834e13a6.
citation: 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.