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
  Purpose

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.


Condition Intervention Phase
Neuromuscular Block
Drug: Placebo
Drug: Lidocaine
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Onset and recovery of the neuromuscular block [ Time Frame: From start of injection of rocuronium until TOF 90% ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 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.
Active Comparator: Lidocaine 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®

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 -
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00828373

Locations
Switzerland
University Hospitals of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Christoph A Czarnetzki, MD, MBA University Hospitals of Geneva
Study Chair: Martin R Tramèr, MD, Dphil University Hospitals of Geneva
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph Czarnetzki, MD, Division of Anesthesiology, University Hospitals of Geneva
ClinicalTrials.gov Identifier: NCT00828373     History of Changes
Other Study ID Numbers: CER 08 - 202, Swissmedic
Study First Received: January 22, 2009
Last Updated: July 14, 2011
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Lidocaine
Rocuronium
Neuromuscular Blocking Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Neuromuscular Nondepolarizing Agents

ClinicalTrials.gov processed this record on September 11, 2014