The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium (LidoRoc)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Intravenous Lidocaine on the Time Course of Rocuronium Induced Neuromuscular Block. A Randomised, Placebo-controlled, Electrophysiological Study|
- Onset and recovery of the neuromuscular block [ Time Frame: From start of injection of rocuronium until TOF 90% ] [ Designated as safety issue: No ]
- To evaluate intubation conditions at T1, we will use the scale according to the Good Clinical Research practice (GRCP) in neuromuscular research [ Time Frame: 2 to 3 minutes ] [ Designated as safety issue: No ]
- Any minor adverse event (no need for intervention) or major adverse event will be recorded. [ Time Frame: up to 5 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 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.
|Active Comparator: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828373
|University Hospitals of Geneva|
|Geneva, Switzerland, 1211|
|Principal Investigator:||Christoph A Czarnetzki, MD, MBA||University Hospitals of Geneva|
|Study Chair:||Martin R Tramèr, MD, Dphil||University Hospitals of Geneva|