Clinical trial NCT00828373: The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium
Official title: The Effect of Intravenous Lidocaine on the Time Course of Rocuronium Induced Neuromuscular Block. A Randomised, Placebo-controlled, Electrophysiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Block
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 -

Primary outcomes:
measure: Onset and recovery of the neuromuscular block
timeFrame: From start of injection of rocuronium until TOF 90%
Secondary outcomes:
measure: To evaluate intubation conditions at T1, we will use the scale according to the Good Clinical Research practice (GRCP) in neuromuscular research
timeFrame: 2 to 3 minutes
measure: Any minor adverse event (no need for intervention) or major adverse event will be recorded.
timeFrame: up to 5 hours
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University Hospitals of Geneva
name: Christoph A Czarnetzki, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals of Geneva
name: Martin R Tramèr, MD, Dphil
role: STUDY_CHAIR
References:
citation: 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.