The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium (LidoRoc)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00828373
First received: January 22, 2009
Last updated: July 14, 2011
Last verified: August 2009

January 22, 2009
July 14, 2011
August 2009
August 2010   (final data collection date for primary outcome measure)
Onset and recovery of the neuromuscular block [ Time Frame: From start of injection of rocuronium until TOF 90% ] [ Designated as safety issue: No ]
Onset time = T 95% depression of the first twitch (T1). Duration 25% = Time from beginning of injection of rocuronium until 25% T1 recovery. Clinical recovery T25-0.9 = Time from 25% T1 recovery to TOF ratio (T1/T4) 0.9 [ Time Frame: 1 to 3 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00828373 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium
The Effect of Intravenous Lidocaine on the Time Course of Rocuronium Induced Neuromuscular Block. A Randomised, Placebo-controlled, Electrophysiological Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuromuscular Block
  • 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.
  • Drug: 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.
    Other Names:
    • Rapidocaïne®
    • Xylocain®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Lidocaine
    Intervention: Drug: Lidocaine
Czarnetzki C, Lysakowski C, Elia N, Tramèr 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
August 2010
August 2010   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00828373
CER 08 - 202, Swissmedic
No
Christoph Czarnetzki, MD, Division of Anesthesiology, University Hospitals of Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Christoph A Czarnetzki, MD, MBA University Hospitals of Geneva
Study Chair: Martin R Tramèr, MD, Dphil University Hospitals of Geneva
University Hospital, Geneva
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP