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

University Hospitals (UH) logo

University Hospitals (UH)

Status and phase

Completed
Phase 4

Conditions

Neuromuscular Block

Treatments

Drug: Placebo
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00828373
Swissmedic
CER 08 - 202

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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 -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

52 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Lidocaine
Active Comparator group
Treatment:
Drug: Lidocaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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