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

NCT00828373 | Completed Phase 4

• 2 other identifiers: CER 08 - 202Swissmedic
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Onset and recovery of the neuromuscular block

  From start of injection of rocuronium until TOF 90%

Secondary Outcomes (2)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Lidocaine

ACTIVE COMPARATOR

Drug: Lidocaine

Interventions

Placebo 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.

Placebo

Lidocaine 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.

Also known as: Rapidocaïne®, Xylocain®

Lidocaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 22260297 DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Christoph A Czarnetzki, MD, MBA

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

• Martin R Tramèr, MD, Dphil

  University Hospitals of Geneva

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 15, 2011

Record last verified: 2009-08

Locations

CH (1)