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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: November 2, 2016
Last verified: November 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • administered dose of propofol during induction of anesthesia [ Time Frame: day 1 ]
  • administered doses of remifentanil during induction and maintenance of anesthesia [ Time Frame: day 1 ]
  • delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia [ Time Frame: day 1 ]
  • hemodynamic abnormalities requiring treatment [ Time Frame: day 1 ]
  • % of time with a BIS index between 40 and 60 [ Time Frame: day 1 ]
  • postoperative morphine requirement [ Time Frame: day 1 ]
  • incidence of postoperative nausea and vomiting [ Time Frame: day 1 ]
  • % of patients with an explicit memorisation of the intraoperative period [ Time Frame: second postoperative day ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
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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
2010-019979-29 ( EudraCT Number )
Study First Received: June 25, 2010
Last Updated: November 2, 2016

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017