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

NCT02483611 | Completed Phase 4 Results DMC

• 2 other identifiers: 5362/201315541213.3.0000.5440
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neuromuscular Block

Keywords

Onset; Recovery; Lidocaine; Cisatracurium; Magnesium sulfate; Isotonic solution

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (24)

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

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

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

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

• MAP - M3 (Mean Arterial Pressure in the 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)

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

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

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

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

Study Arms (3)

Group M

EXPERIMENTAL

Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery. After the bolus of magnesium sulfate, 0.15 mg/kg of cisatracurium was infused over 5 seconds.

Drug: Magnesium Sulfate; Drug: Cisatracurium

Group ML

EXPERIMENTAL

Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery. After the bolus of magnesium sulfate and lidocaine, 0.15 mg/kg of cisatracurium was infused over 5 seconds

Drug: Magnesium Sulfate; Drug: Lidocaine; Drug: Cisatracurium

Group C

PLACEBO COMPARATOR

Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups. After the bolus of the isotonic solution , 0.15 mg/kg of cisatracurium was infused over 5 seconds

Drug: Isotonic Solution; Drug: Cisatracurium

Interventions

Magnesium Sulfate DRUG

Group M; Group ML

Lidocaine DRUG

Group ML

Isotonic Solution DRUG

Group C

Cisatracurium DRUG

Also known as: Nimbex

Group C; Group M; Group ML

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I or II
• BMI between 18 and 29

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (31)

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• Paula-Garcia WN, Oliveira-Paula GH, de Boer HD, Garcia LV. Lidocaine combined with magnesium sulfate preserved hemodynamic stability during general anesthesia without prolonging neuromuscular blockade: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2021 Mar 27;21(1):91. doi: 10.1186/s12871-021-01311-y.

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MeSH Terms

Interventions

Magnesium Sulfate; Lidocaine; Isotonic Solutions; cisatracurium

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Solutions; Pharmaceutical Preparations

Limitations and Caveats

-It was not possible to measure Magnesium sulfate and Lidocaine levels

Results Point of Contact

• Title: Dra Waynice Neiva de Paula Garcia
• Organization: University of Sao Paulo

waynicegarcia@gmail.com

551636021000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 29, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 15, 2016
• Results First Posted: January 15, 2016

Record last verified: 2015-12