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Lidocaine and Closed-Loop Anesthesia System (LoopLido)

This study is currently recruiting participants.
Verified July 2012 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01154738
First received: June 25, 2010
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.


Condition Intervention Phase
Anesthesia
 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (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 mg.kg-1) followed by an infusion of lidocaine (2 mg.kg-1 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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154738

Contacts
Contact: Marc Fischler Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
Hopital Tenon Recruiting
Paris, France, 75020
Contact: Francis Bonnet, MD     56016571 ext 00331     francis.bonnet@tnn.aphp.fr    
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01154738     History of Changes
Other Study ID Numbers: 2010/18
Study First Received: June 25, 2010
Last Updated: July 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013