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

NCT ID: NCT00828373

Last Updated: 2011-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-08-31

Brief Summary

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.

Conditions

Neuromuscular Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Lidocaine

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Rapidocaïne®; Xylocain®

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Division of Anesthesiology, University Hospitals of Geneva

Principal Investigators

Christoph A Czarnetzki, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Geneva

Martin R Tramèr, MD, Dphil

Role: STUDY_CHAIR

University Hospitals of Geneva

Locations

University Hospitals of Geneva

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 22260297 (View on PubMed)

Other Identifiers

Swissmedic

Identifier Type: -

Identifier Source: secondary_id

CER 08 - 202

Identifier Type: -

Identifier Source: org_study_id