The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium

Study Overview
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Brief Summary
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Lidocaine is a local anesthetic which is widely used in daily anesthesia and surgical practice. It has been shown that intravenous lidocaine given during an operation has analgesic properties. Finally intravenous lidocaine is inexpensive and easy to administer and safe if non-toxic doses are respected. It is likely that the use of lidocaine infusions during anesthesia might increase in the coming years. Neuromuscular blockers (curare like substances) are used in anesthesia to facilitate tracheal intubation and to achieve muscle relaxation and immobility during surgery. Rocuronium is one of the most widely used neuromuscular blocking agents. Local anesthetics, such as lidocaine, are known to potentiate the effect of neuromuscular blocking agents. In the study the investigators want to evaluate the effect of intravenous lidocaine during the operation on the time course of the rocuronium-induced neuromuscular block. A secondary aim is to evaluate intubation conditions (lidocaine has been shown also to improve intubation conditions) and safety.

Official Title
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The Effect of Intravenous Lidocaine on the Time Course of Rocuronium Induced Neuromuscular Block. A Randomised, Placebo-controlled, Electrophysiological Study

Conditions
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Neuromuscular Block

Intervention / Treatment
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* Drug: Placebo
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, age ≥18 to 60 years, male or female. American Society of Anesthesiology [ASA] status I or II. Patient is able to read and understand the information sheet and to sign and date the consent form. Patient scheduled of elective surgery lasting longer than 120 min without need for continuous curarisation. Surgery without application of local anesthetics (epidurals, wound-infiltration). If the patient is female and of childbearing potential, she must have a negative pregnancy test. Exclusion Criteria: A history of allergy or hypersensitivity to rocuronium or lidocaine Neuromuscular disease Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics [aminoglycosides] and anticonvulsants [phenytoine]) Electrolyte abnormalities (for instance, hypermagnesemia) Hepatic or renal insufficiency Patients with epileptic disease Patients with a body mass index <19 or >28 kg m2 Pregnant or breastfeeding women Expected difficult intubation or mask ventilation Atrioventricular heart block II or III -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Immediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the Placebo group this will be physiologic saline. The infusion will be stopped after complete recovery from the neuromuscular block.<br>|
| Active Comparator: Lidocaine<br> | Drug: Lidocaine<br>* Immediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the lidocaine Arm this regimen corresponds to 1.5 mg kg-1 lidocaine bolus injection and 2 mg kg-1 h-1 lidocaine continuous infusion. The infusion will be stopped after complete recovery from the neuromuscular block.<br>* Other names: Xylocain®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset and recovery of the neuromuscular block |  | From start of injection of rocuronium until TOF 90% | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate intubation conditions at T1, we will use the scale according to the Good Clinical Research practice (GRCP) in neuromuscular research |  | 2 to 3 minutes | 
| Any minor adverse event (no need for intervention) or major adverse event will be recorded. |  | up to 5 hours |