Neuromuscular Block Clinical Trial
Official title:
Effect of Intravenous Infusion of Magnesium Sulfate Associated or Not to Lidocaine On the Neuromuscular Blockade Induced by Muscle Relaxant Cistracurium
The magnesium sulfate and lidocaine have been increasingly used alone or in combination
during anesthesia procedure to meet various objectives, such as reduction of pain, use of
smaller anesthetic doses and stabilization of hemodynamic parameters.
These medicines are often used in combination with neuromuscular blocking agents, which may
contribute to the occurrence of residual block in some patients after anesthetic procedures.
It was estimated that only 1-3 % of patients with residual block developing clinically
apparent events. In a small proportion of patients, the consequences of residual blockade
are very serious and even lethal. It is estimated that 40 % of patients with muscle
paralysis come to the post-anesthesia care unit (PACU).
Considering that: (a) magnesium sulfate and lidocaine are showing an increasing number of
applications in various areas of medicine, (b) these medications stand out for their
properties analgesic, anti-inflammatory, anti-arrhythmic, neuroprotective and capable of
reducing the demand of anesthetics and opioids, (c) magnesium sulfate as lidocaine has been
important part of the therapeutic arsenal to control a large number of diseases (d) the
patient surgical surgery or potentially have benefited in particular from its effects, (and)
these drugs have been used routinely in many medical services as well as adjuvants in
anesthesia, (f) previous studies have shown that magnesium sulfate is able to prolong the
duration of neuromuscular blockade by different types of muscle relaxants, with
controversies about its effect on latency (g) the effect of lidocaine on the action of
muscle relaxants in current literature have shown great controversy and (h) do not exist in
the literature studies involving both drugs; the investigators aimed to investigate the
effects of magnesium sulphate infused alone or associated with lidocaine on the
neuromuscular blockade promoted by cisatracurium, as well as evaluate its possible
hemodynamic repercussions. For this purpose the SM was infused in bolus, prior to tracheal
intubation and continuously during the maintenance of general anesthesia; the Lidocaine,
when associated and the Isotonic Solution were used in the same way and timeline as SM. As
secondary objectives it has been proposed to evaluate if the Lidocaine with Magnesium
Sulfate would be able to interfere with the hemodynamic stability of the patients in the
study.
The study was approved by the Medical Research Ethics Committee of the Hospital das
Clinicas, of the Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Brazil; Its
Unique Protocol ID is 5362/2013. This study was conducted with free written informed consent
from the study subjects.
This report describes a prospective randomized clinical trial. The author states that the
report includes every item in the checklist for a prospective randomized clinical trial.
The study was registered prior to patient enrollment. Forty‐eight American Society of
Anesthesiology patient classification status ASA I and II undergoing elective surgery were
divided into three parallel groups. The M group received MS 40 mg.kg-1 as a bolus before the
induction of anesthesia and 20mg.kg-1h-1 via continuous i.v. infusion during the operation
period. The ML group received identical doses of MS combined with lidocaine 3 mg.kg-1 as a
bolus before the induction of anesthesia and 3 mg.kg-1h-1 via continuous i.v. infusion
during the operation period. The control group was administered a equivalent volume of
isotonic solution. Anesthesia was maintained via propofol and remifentanil infusions. After
loss of patient consciousness and administration of the bolus infusions, a 0.15 mg.kg-1
bolus of cisatracurium was administered to the patient over 5 s. No additional cisatracurium
injections were performed. The patient's neuromuscular function was assessed every 15 s by
measuring the adductor polis with a TOF Watch SX acceleromyograph. The primary endpoint was
the time at which spontaneous recovery of a train-of-four (TOF) ratio of 90% as achieved.
The systolic, diastolic and mean and heart rate were recorded and annotated at various
times: M1- when the patient arrived in the operating room; M2- immediately before induction
of anesthesia; M3- before the infusion of the tested solutions (saline, magnesium sulphate
or magnesium sulphate associated with lidocaine); M4- five minutes after M3 (end of infusion
loading dose of test solutions); M5 immediately before intubation; M6- one minute after
tracheal intubation and M7 (a through f) - every fifteen minutes until the end of the study.
The sample size was calculated with a power of 80% to detect differences of 20% in the
timing of clinical onset and the duration of the neuromuscular blockade (NMB). Quantitative
variables were described as mean ± standard deviation. The normality of the distributions
was tested for all variables in each group, using the non-parametric test of Shapiro-Wilk.
When the variable normally distributed, we used the analysis of variance test (ANOVA) for
comparison between groups. When differences were found between the groups, we used the Tukey
test for multiple comparisons. When the variable is not normally distributed by applying the
Shapiro-Wilk test, we used the Kruskal-Wallis test to compare the groups. When differences
were found between the groups, we used the Dunn test for multiple comparisons. The critical
level of significance was 5%.
During the analysis of the recovery characteristics of the neuromuscular blockade, all
parameters based on the T1 response (DUR 25% DUR 75% and DUR 95%) were normalized
considering the final T1 value when this response did not return to baseline (VIBY-MOGENSEN
et al., 1996).
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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