CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
Magnesium Sulfate +3 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02483611
NCT02483611Phase 4Completed

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

University of Sao Paulo·interventional·Posted Jun 29, 2015·Updated Jan 15, 2016

In Brief

A Phase 4 clinical trial evaluating Magnesium Sulfate, Lidocaine, and 2 other interventions for Neuromuscular Block. Completed, enrolled 48 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
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Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 29, 2015
Enrollment StartJul 1, 2015
Primary CompletionAug 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.0 years ago

Interventions

Magnesium Sulfatedrug

Lidocainedrug

Isotonic Solutiondrug

Cisatracuriumdrug