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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483611
• Other study ID #: 5362/2013
• Secondary ID: 15541213.3.0000.
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2015
• Last updated: December 10, 2015
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Neuromuscular Block

Intervention

Drug:
• Magnesium Sulfate

• Lidocaine

• Isotonic Solution

• Cisatracurium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

References & Publications (30)

Cardoso LS, Martins CR, Tardelli MA. Effects of intravenous lidocaine on the pharmacodynamics of rocuronium. Rev Bras Anestesiol. 2005 Aug;55(4):371-80. English, Portuguese. — View Citation

Czarnetzki C, Lysakowski C, Elia N, Tramèr MR. Intravenous lidocaine has no impact on rocuronium-induced neuromuscular block. Randomised study. Acta Anaesthesiol Scand. 2012 Apr;56(4):474-81. doi: 10.1111/j.1399-6576.2011.02625.x. Epub 2012 Jan 19. — View Citation

Czarnetzki C, Lysakowski C, Elia N, Tramèr MR. Time course of rocuronium-induced neuromuscular block after pre-treatment with magnesium sulphate: a randomised study. Acta Anaesthesiol Scand. 2010 Mar;54(3):299-306. doi: 10.1111/j.1399-6576.2009.02160.x. E — View Citation

Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. — View Citation

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Germano Filho PA, Cavalcanti IL, Barrucand L, Verçosa N. Effect of magnesium sulphate on sugammadex reversal time for neuromuscular blockade: a randomised controlled study. Anaesthesia. 2015 Aug;70(8):956-61. doi: 10.1111/anae.12987. Epub 2015 Apr 1. — View Citation

Ghodraty MR, Saif AA, Kholdebarin AR, Rokhtabnak F, Pournajafian AR, Nikzad-Jamnani AR, Shah A, Nader ND. The effects of magnesium sulfate on neuromuscular blockade by cisatracurium during induction of anesthesia. J Anesth. 2012 Dec;26(6):858-63. doi: 10. — View Citation

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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

Hans GA, Defresne A, Ki B, Bonhomme V, Kaba A, Legrain C, Brichant JF, Hans PC. Effect of an intravenous infusion of lidocaine on cisatracurium-induced neuromuscular block duration: a randomized-controlled trial. Acta Anaesthesiol Scand. 2010 Nov;54(10):1192-6. doi: 10.1111/j.1399-6576.2010.02304.x. Epub 2010 Sep 14. — View Citation

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Kim MH, Oh AY, Han SH, Kim JH, Hwang JW, Jeon YT. The effect of magnesium sulphate on intubating condition for rapid-sequence intubation: a randomized controlled trial. J Clin Anesth. 2015 Nov;27(7):595-601. doi: 10.1016/j.jclinane.2015.07.002. Epub 2015 Aug 25. — View Citation

Kim MH, Oh AY, Jeon YT, Hwang JW, Do SH. A randomised controlled trial comparing rocuronium priming, magnesium pre-treatment and a combination of the two methods. Anaesthesia. 2012 Jul;67(7):748-54. doi: 10.1111/j.1365-2044.2012.07102.x. Epub 2012 Mar 15. — View Citation

Kim SH, So KY, Jung KT. Effect of magnesium sulfate pretreatment on onset and recovery characteristics of cisatracurium. Korean J Anesthesiol. 2012 Jun;62(6):518-23. doi: 10.4097/kjae.2012.62.6.518. Epub 2012 Jun 19. — View Citation

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Loyola YC, Braga Ade F, Potério GM, Sousa SR, Fernandes SC, Braga FS. [Influence of lidocaine on the neuromuscular block produced by rocuronium: study in rat phrenic-diaphragmatic nerve preparation.]. Rev Bras Anestesiol. 2006 Apr;56(2):147-56. Portuguese — View Citation

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Rotava P, Cavalcanti IL, Barrucand L, Vane LA, Verçosa N. Effects of magnesium sulphate on the pharmacodynamics of rocuronium in patients aged 60 years and older: A randomised trial. Eur J Anaesthesiol. 2013 Oct;30(10):599-604. doi: 10.1097/EJA.0b013e3283 — View Citation

Shahrami A, Assarzadegan F, Hatamabadi HR, Asgarzadeh M, Sarehbandi B, Asgarzadeh S. Comparison of therapeutic effects of magnesium sulfate vs. dexamethasone/metoclopramide on alleviating acute migraine headache. J Emerg Med. 2015 Jan;48(1):69-76. doi: 10.1016/j.jemermed.2014.06.055. Epub 2014 Sep 30. — View Citation

Staals LM, Driessen JJ, Van Egmond J, De Boer HD, Klimek M, Flockton EA, Snoeck MM. Train-of-four ratio recovery often precedes twitch recovery when neuromuscular block is reversed by sugammadex. Acta Anaesthesiol Scand. 2011 Jul;55(6):700-7. doi: 10.1111 — View Citation

Toft P, Kirkegaard Nielsen H, Severinsen I, Helbo-Hansen HS. Effect of epidurally administered bupivacaine on atracurium-induced neuromuscular blockade. Acta Anaesthesiol Scand. 1990 Nov;34(8):649-52. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency	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.	Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes	Yes
Primary	Clinical Duration	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.	Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes	Yes
Primary	Recovery Index	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.	Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes	Yes
Primary	Final Recovery Index	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.	Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes	Yes
Primary	Total Duration (Dur95%)	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.	Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes	Yes
Primary	Spontaneous Recovery (T4/T1=90%)	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.	The participants were followed during the anesthetic - surgical procedure	Yes
Secondary	MAP - M1 (Mean Arterial Pressure in the Moment 1)	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'.	This measure of average blood pressure was performed when the patient arrived in the operating room	Yes
Secondary	MAP - M2 (Mean Arterial Pressure in the Moment 2)	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'.	This measure of average blood pressure was performed immediately before induction of anesthesia	Yes
Secondary	MAP - M3 (Mean Arterial Pressure in the Moment 3)	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'.	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)	Yes
Secondary	MAP - M4 (Mean Arterial Pressure in the Moment 4)	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'.	This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion)	Yes
Secondary	MAP - M5 (Mean Arterial Pressure in the Moment 5)	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'.	This measure of average blood pressure was performed immediately before the tracheal intubation	Yes
Secondary	MAP - M6 (Mean Arterial Pressure in the Moment 6)	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'.	This measure of average blood pressure was performed one minute after the tracheal intubation	Yes
Secondary	HR - M1 (Heart Rate in the Moment 1)	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'.	This measure of heart rate was performed when the patient arrived in the operating room	Yes
Secondary	HR - M2 (Heart Rate in the Moment 2)	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'.	This measure of heart rate was performed immediately before induction of anesthesia	Yes
Secondary	HR - M3 (Heart Rate in the Moment 3)	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'.	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)	Yes
Secondary	HR - M4 (Heart Rate in the Moment 4)	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'.	This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion)	Yes
Secondary	HR - M5 (Heart Rate in the Moment 5)	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'.	This measure of heart rate was performed immediately before the tracheal intubation	Yes
Secondary	HR - M6 (Heart Rate in the Moment 6)	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'.	This measure of heart rate was performed one minute after the tracheal intubation	Yes
Secondary	MAP - M7a (Mean Arterial Pressure in the Moment 7a)	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'.	This measure of average blood pressure was performed 15 minutes after the traqueal intubation	Yes
Secondary	MAP - M7b (Mean Arterial Pressure in the Moment 7b)	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'.	This measure of average blood pressure was performed 30 minutes after the traqueal intubation	Yes
Secondary	MAP - M7c (Mean Arterial Pressure in the Moment 7c)	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'.	This measure of average blood pressure was performed 45 minutes after the traqueal intubation	Yes
Secondary	MAP - M7d (Mean Arterial Pressure in the Moment 7d)	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'.	This measure of average blood pressure was performed 60 minutes after the traqueal intubation	Yes
Secondary	MAP - M7e (Mean Arterial Pressure in the Moment 7e)	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'.	This measure of average blood pressure was performed 75 minutes after the traqueal intubation	Yes
Secondary	MAP - M7f (Mean Arterial Pressure in the Moment 7f)	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'.	This measure of average blood pressure was performed 90 minutes after the traqueal intubation	Yes
Secondary	HR - M7a (Heart Rate in the Moment 7a)	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'.	This measure of heart rate was performed 15 minutes after the traqueal intubation	Yes
Secondary	HR - M7b (Heart Rate in the Moment 7b)	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'.	This measure of heart rate was performed 30 minutes after the traqueal intubation	Yes
Secondary	HR - M7c (Heart Rate in the Moment 7c)	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'.	This measure of heart rate was performed 45 minutes after the traqueal intubation	Yes
Secondary	HR - M7d (Heart Rate in the Moment 7d)	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'.	This measure of heart rate was performed 60 minutes after the traqueal intubation	Yes
Secondary	HR - M7e (Heart Rate in the Moment 7e)	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'.	This measure of heart rate was performed 75 minutes after the traqueal intubation	Yes
Secondary	HR - M7f (Heart Rate in the Moment 7f)	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'.	This measure of heart rate was performed 90 minutes after the traqueal intubation	Yes