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Lidocaine and Closed-Loop Anesthesia System (LoopLido)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01154738
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Tracking Information
First Submitted Date  ICMJE June 25, 2010
First Posted Date  ICMJE July 1, 2010
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
administered dose of propofol during maintenance of anesthesia [ Time Frame: day 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine and Closed-Loop Anesthesia System
Official Title  ICMJE Influence of Lidocaine on a Closed-Loop Anesthesia System
Brief Summary The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • 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

Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2016)
82
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2010)
80
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01154738
Other Study ID Numbers  ICMJE 2010/18
2010-019979-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hopital Foch
Study Sponsor  ICMJE Hopital Foch
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Marc Fischler, MD Hôpital Foch
PRS Account Hopital Foch
Verification Date November 2016

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