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

Neuromuscular Block Clinical Trial

— LidoRoc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828373
• Other study ID #: CER 08 - 202
• Secondary ID: Swissmedic
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2009
• Last updated: July 14, 2011
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neuromuscular Block

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset and recovery of the neuromuscular block		From start of injection of rocuronium until TOF 90%	No
Secondary	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	No
Secondary	Any minor adverse event (no need for intervention) or major adverse event will be recorded.		up to 5 hours	Yes