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NCT Number: NCT02483611

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

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.

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Key information

Conditions

Neuromuscular Block

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

Lidocaine

Drug

Isotonic Solution

Drug

Cisatracurium

Drug

Other names: Nimbex

Primary outcomes

  1. Latency

    Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

    The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium.

    This outcome meansure was presented in seconds.

  2. Clinical Duration

    Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

    The clinical duration is the elapsed time for T1 recovery = 25% (Dur25%) of the original value of T1 after the infusion of cisatracurium.

    This outcome meansure was presented in minutes.

  3. Recovery Index

    Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

    The recovery index is the elapsed time between the T1 recovery =25% (Dur25%) and T1 =75% (Dur75%) after the infusion of cisatracurium.

    This outcome meansure was presented in minutes.

  4. Final Recovery Index

    Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

    The final recovery index is the elapsed time between the T1 recovery = 25% (Dur25%) and T4 / T1 = 80% (TOF = 80%) after the infusion of cisatracurium.

    This outcome measure was presented in minutes.

  5. Total Duration (Dur95%)

    Time frame: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

    The total duration is the elapsed time for T1 recovery of the response to reach 95% of the initial after the infusion of cisatracurium.

    This outcome measure was presented in minutes.

  6. Spontaneous Recovery (T4/T1=90%)

    Time frame: The participants were followed during the anesthetic - surgical procedure

    Spontaneous recovery is the elapsed time for the recovery of the TOF (T4 / T1) response to 90% of the original after infusion of cisatracurium.

    This outcome measure was presented in minutes.

Secondary outcomes

  1. MAP - M1 (Mean Arterial Pressure in the Moment 1)

    Time frame: This measure of average blood pressure was performed when the patient arrived in the operating room

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.

  2. MAP - M2 (Mean Arterial Pressure in the Moment 2)

    Time frame: This measure of average blood pressure was performed immediately before induction of anesthesia

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.

  3. MAP - M3 (Mean Arterial Pressure in the Moment 3)

    Time frame: This measure of average blood pressure was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.

  4. MAP - M4 (Mean Arterial Pressure in the Moment 4)

    Time frame: This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion)

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the end of the study solutions infusion.This time point was named as moment '4'.

  5. MAP - M5 (Mean Arterial Pressure in the Moment 5)

    Time frame: This measure of average blood pressure was performed immediately before the tracheal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.

  6. MAP - M6 (Mean Arterial Pressure in the Moment 6)

    Time frame: This measure of average blood pressure was performed one minute after the tracheal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.

  7. HR - M1 (Heart Rate in the Moment 1)

    Time frame: This measure of heart rate was performed when the patient arrived in the operating room

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The measure of heart rate was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.

  8. HR - M2 (Heart Rate in the Moment 2)

    Time frame: This measure of heart rate was performed immediately before induction of anesthesia

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.

  9. HR - M3 (Heart Rate in the Moment 3)

    Time frame: This measure of heart rate was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.

  10. HR - M4 (Heart Rate in the Moment 4)

    Time frame: This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion)

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the end of the study solutions infusion. This time point was named as moment '4'.

  11. HR - M5 (Heart Rate in the Moment 5)

    Time frame: This measure of heart rate was performed immediately before the tracheal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.

  12. HR - M6 (Heart Rate in the Moment 6)

    Time frame: This measure of heart rate was performed one minute after the tracheal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.

  13. MAP - M7a (Mean Arterial Pressure in the Moment 7a)

    Time frame: This measure of average blood pressure was performed 15 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 15 minutes after the traqueal intubation. This time point was named as moment '7a'.

  14. MAP - M7b (Mean Arterial Pressure in the Moment 7b)

    Time frame: This measure of average blood pressure was performed 30 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.

  15. MAP - M7c (Mean Arterial Pressure in the Moment 7c)

    Time frame: This measure of average blood pressure was performed 45 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.

  16. MAP - M7d (Mean Arterial Pressure in the Moment 7d)

    Time frame: This measure of average blood pressure was performed 60 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.

  17. MAP - M7e (Mean Arterial Pressure in the Moment 7e)

    Time frame: This measure of average blood pressure was performed 75 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.

  18. MAP - M7f (Mean Arterial Pressure in the Moment 7f)

    Time frame: This measure of average blood pressure was performed 90 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.

  19. HR - M7a (Heart Rate in the Moment 7a)

    Time frame: This measure of heart rate was performed 15 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 15 minutes after the traqueal intubation.This time point was named as moment '7a'.

  20. HR - M7b (Heart Rate in the Moment 7b)

    Time frame: This measure of heart rate was performed 30 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.

  21. HR - M7c (Heart Rate in the Moment 7c)

    Time frame: This measure of heart rate was performed 45 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.

  22. HR - M7d (Heart Rate in the Moment 7d)

    Time frame: This measure of heart rate was performed 60 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.

  23. HR - M7e (Heart Rate in the Moment 7e)

    Time frame: This measure of heart rate was performed 75 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.

  24. HR - M7f (Heart Rate in the Moment 7f)

    Time frame: This measure of heart rate was performed 90 minutes after the traqueal intubation

    In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effect of Intravenous Infusion of Magnesium Sulfate Associated or Not to Lidocaine On the Neuromuscular Blockade Induced by Muscle Relaxant Cistracurium

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 29, 2015
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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