Lidocaine and Closed-Loop Anesthesia System (LoopLido)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01154738
First received: June 25, 2010
Last updated: January 7, 2014
Last verified: January 2014

June 25, 2010
January 7, 2014
January 2011
June 2014   (final data collection date for primary outcome measure)
administered dose of propofol during maintenance of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01154738 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lidocaine and Closed-Loop Anesthesia System
Influence of Lidocaine on a Closed-Loop Anesthesia System

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Anesthesia
  • 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

  • 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

  • Experimental: Lidocaine
    Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo
    patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Marc Fischler Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org
France
 
NCT01154738
2010/18
No
Hopital Foch
Hopital Foch
Not Provided
Study Chair: Marc Fischler, MD Hôpital Foch
Hopital Foch
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP