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

Condition(s) targeted: Neuromuscular Block

Intervention: Placebo (Drug); Lidocaine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital, Geneva

Official(s) and/or principal investigator(s):
Christoph A Czarnetzki, MD, MBA, Principal Investigator, Affiliation: University Hospitals of Geneva
Martin R Tramèr, MD, Dphil, Study Chair, Affiliation: University Hospitals of Geneva

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Onset and recovery of the neuromuscular block

Secondary outcome:

To evaluate intubation conditions at T1, we will use the scale according to the Good Clinical Research practice (GRCP) in neuromuscular research

Any minor adverse event (no need for intervention) or major adverse event will be recorded.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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 -

University Hospitals of Geneva, Geneva 1211, Switzerland

Starting date: August 2009
Last updated: July 14, 2011