The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium (LidoRoc)

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

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Block
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 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.
Active Comparator: Lidocaine	Drug: Lidocaine; 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.; Other Names: Rapidocaïne®; Xylocain®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Christoph A Czarnetzki, MD, MBA, University Hospitals of Geneva; Study Chair: Martin R Tramer, MD, Dphil, University Hospitals of Geneva

Publications and helpful links

General Publications

• Czarnetzki C, Lysakowski C, Elia N, Tramer 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 22, 2009
• First Posted (Estimate): January 23, 2009

Study Record Updates

• Last Update Posted (Estimate): July 15, 2011
• Last Update Submitted That Met QC Criteria: July 14, 2011
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: CER 08 - 202; Swissmedic