Lidocaine and Closed-Loop Anesthesia System (LoopLido)

This study has been completed.
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: June 25, 2010
Last updated: April 19, 2016
Last verified: April 2016
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.

Condition Intervention Phase
Drug: Lidocaine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Lidocaine on a Closed-Loop Anesthesia System

Resource links provided by NLM:

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • administered dose of propofol during maintenance of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • administered dose of propofol during induction of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • administered doses of remifentanil during induction and maintenance of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • hemodynamic abnormalities requiring treatment [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • % of time with a BIS index between 40 and 60 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • postoperative morphine requirement [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • incidence of postoperative nausea and vomiting [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • % of patients with an explicit memorisation of the intraoperative period [ Time Frame: second postoperative day ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: January 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine
Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine
Drug: Lidocaine

bolus dose of lidocaine (1.5 followed by an infusion of lidocaine (2 h-1) until the end of anesthesia.

start of the induction of anesthesia 10 minutes after the bolus dose of lidocaine

Placebo Comparator: Placebo
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
Drug: Placebo

NaCl 9/00 (same volume as in the lidocaine group)

start of the induction of anesthesia 10 minutes after the bolus dose of NaCl 9/00


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients ASA 1, 2 or 3 scheduled for a general anesthesia surgical procedure (abdominal surgery, urology, ENT major procedure) lasting between 1 and 3 hours

Exclusion Criteria:

  • age under 18 years
  • simultaneous general and loco-regional anesthesia
  • allergy to NSAID
  • treatment with verapamil, ketamine or gabapentin
  • patients receiving an opioid preoperatively
  • severe hepatic insufficiency
  • contra-indication to lidocaine
  • contra-indication to propofol or to remifentanil
  • history of central nervous system disease
  • patients receiving a psychotropic treatment
  • patients with a pace-maker
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Please refer to this study by its identifier: NCT01154738

Hopital Tenon
Paris, France, 75020
Sponsors and Collaborators
Hopital Foch
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

Responsible Party: Hopital Foch Identifier: NCT01154738     History of Changes
Other Study ID Numbers: 2010/18 
Study First Received: June 25, 2010
Last Updated: April 19, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers processed this record on April 27, 2016