The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium - Full Text View

Sponsored by:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00828373

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacodynamics Study
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:

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: ORG 9426 Rocuronium Lidocaine

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

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 ]

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 ]

Estimated Enrollment:	50
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	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.
Lidocaine: Active Comparator	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.

Arms

Assigned Interventions

Placebo: Placebo Comparator

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.

Lidocaine: Active Comparator

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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828373

Contacts

Contact: Christoph A Czarnetzki, MD, MBA	0041223723311	christoph.czarnetzki@hcuge.ch
Contact: Martin R Tramèr, MD, Dphil	0041223723311	martin.tramer@hcuge.ch

Locations

Switzerland
University Hospitals of Geneva	Recruiting
Geneva, Switzerland, 1211
Contact: Christoph A Czarnetzki, MD, MBA 0041223723311 ext 7958558 christoph.czarnetzki@hcuge.ch
Contact: Martin R Tramèr, MD, Dphil 0041223723311 ext 7958621 martin.tramer@hcuge.ch
Sub-Investigator: Christopher Lysakowski, MD
Sub-Investigator: Emmanuel Marret, MD

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

Responsible Party:	Division of Anesthesiology, University Hospitals of Geneva ( Christoph Czarnetzki, MD )
Study ID Numbers:	CER 08 - 202, Swissmedic
Study First Received:	January 22, 2009
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00828373 History of Changes
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Neuromuscular Nondepolarizing Agents
Rocuronium
Lidocaine
Central Nervous System Depressants
Anesthetics

Neuromuscular Blocking Agents
Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Anesthetics, Local

Additional relevant MeSH terms:

Neuromuscular Nondepolarizing Agents
Rocuronium
Physiological Effects of Drugs
Lidocaine
Anesthetics
Central Nervous System Depressants
Neuromuscular Agents
Neuromuscular Blocking Agents

Cardiovascular Agents
Anesthetics, Local
Pharmacologic Actions
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009