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NCT Number: NCT00828373

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

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.

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Key information

Conditions

Neuromuscular Block

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals of Geneva

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Placebo

Drug

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

Drug

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®

Primary outcomes

  1. Onset and recovery of the neuromuscular block

    Time frame: From start of injection of rocuronium until TOF 90%

Secondary outcomes

  1. 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

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

    Time frame: up to 5 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Acronym: LidoRoc

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 23, 2009
Registry last updated
Jul 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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