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Phase 4 N=48 Randomized Triple-blind

Effects of Intravenous Lidocaine Associated With Magnesium Sulfate on the Cisatracurium-Induced Neuromuscular Block

Neuromuscular Block

Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Latency — 139.70; 151.30; 147.80 seconds — p=0.9651

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Magnesium Sulfate (Drug); Lidocaine (Drug); Isotonic Solution (Drug); Cisatracurium (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Sao Paulo
Primary completion
Aug 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Latency
139.70; 151.30; 147.80 0.9651
PRIMARY
Clinical Duration
82.68; 86.33; 64.8 <0.0001 sig
PRIMARY
Recovery Index
20.08; 20.26; 14.53 0.0015 sig
PRIMARY
Final Recovery Index
27.97; 33.81; 21.51 0.0003 sig
PRIMARY
Total Duration (Dur95%)
113.20; 120.10; 88.19 <0.0001 sig
PRIMARY
Spontaneous Recovery (T4/T1=90%)
120.20; 126.70; 90.03 <0.0001 sig
SECONDARY
MAP - M1 (Mean Arterial Pressure in the Moment 1)
94.63; 88.75; 100.10 0.0527
SECONDARY
MAP - M2 (Mean Arterial Pressure in the Moment 2)
87.63; 84.69; 92.47 0.1996
SECONDARY
MAP - M3 (Mean Arterial Pressure in the Moment 3)
75.88; 73.88; 76.73 0.7145
SECONDARY
MAP - M4 (Mean Arterial Pressure in the Moment 4)
69.00; 63.00; 74.00 0.1130
SECONDARY
MAP - M5 (Mean Arterial Pressure in the Moment 5)
62.50; 61.50; 67.00 0.0731
SECONDARY
MAP - M6 (Mean Arterial Pressure in the Moment 6)
64.50; 64.00; 69.00 0.1002
SECONDARY
HR - M1 (Heart Rate in the Moment 1)
79.94; 77.25; 73.66 0.4338
SECONDARY
HR - M2 (Heart Rate in the Moment 2)
74.69; 73.69; 75.40 0.9167
SECONDARY
HR - M3 (Heart Rate in the Moment 3)
72.94; 74.19; 75.40 0.8067
SECONDARY
HR - M4 (Heart Rate in the Moment 4)
71.94; 72.25; 65.07 0.1015
SECONDARY
HR - M5 (Heart Rate in the Moment 5)
67.56; 69.31; 64.27 0.3423
SECONDARY
HR - M6 (Heart Rate in the Moment 6)
66.50; 68.19; 65.13 0.6817
SECONDARY
MAP - M7a (Mean Arterial Pressure in the Moment 7a)
66.00; 61.50; 69.00 0.0937
SECONDARY
MAP - M7b (Mean Arterial Pressure in the Moment 7b)
66.50; 63.50; 68.00 0.1406
SECONDARY
MAP - M7c (Mean Arterial Pressure in the Moment 7c)
69.25; 63.00; 69.00 0.0504
SECONDARY
MAP - M7d (Mean Arterial Pressure in the Moment 7d)
68.00; 62.00; 66.00 0.0205 sig
SECONDARY
MAP - M7e (Mean Arterial Pressure in the Moment 7e)
68.00; 66.00; 69.00 0.3004
SECONDARY
MAP - M7f (Mean Arterial Pressure in the Moment 7f)
64.00; 64.50; 72.00 0.0178 sig
SECONDARY
HR - M7a (Heart Rate in the Moment 7a)
68.94; 68.19; 67.13 0.8746
SECONDARY
HR - M7b (Heart Rate in the Moment 7b)
67.44; 68.38; 64.00 0.4195
SECONDARY
HR - M7c (Heart Rate in the Moment 7c)
65.75; 65.75; 62.33 0.5796
SECONDARY
HR - M7d (Heart Rate in the Moment 7d)
66.19; 65.31; 61.93 0.5351
SECONDARY
HR - M7e (Heart Rate in the Moment 7e)
66.50; 63.00; 58.00 0.4988
SECONDARY
HR - M7f (Heart Rate in the Moment 7f)
66.00; 61.00; 61.00 0.7723

Summary

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.

Eligibility Criteria

Before the recruitment of patients, the study was approved by Brazil Platform (a national and unified basis of research involving human subjects records) and published by the ClinicalTrials.gov

Inclusion Criteria

  • ASA I or II
  • BMI between 18 and 29

Exclusion Criteria

  • Use of medications that could affect the neuromuscular blockade such as calcium channel inhibitors, anticonvulsants and lithium carbonate
  • Presence of neuromuscular, renal or hepatic dysfunction.
  • Hypermetabolic or hypometabolic states such as fever, infection, and hyperthyroidism or hypothyroidism
  • Acid-base disorder, congestive heart failure or conductive heart problems, and those who were being treated for cardiac arrhythmias
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02483611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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