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CompletedNCT01154738LoopLidoUpdated Nov 3, 2016

Lidocaine and Closed-Loop Anesthesia System

A Phase 3 interventional study of Lidocaine and Placebo in Anesthesia, sponsored by Hopital Foch. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-03.

Sponsored by Hopital Foch · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Lidocaine

    Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine

    Drug: Lidocaine

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugLidocaine

    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

  • DrugPlacebo

    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

06

What researchers measure

Primary outcomes

  1. administered dose of propofol during maintenance of anesthesia

    Time frame: day 1

Secondary outcomes

  1. administered dose of propofol during induction of anesthesia

    Time frame: day 1

  2. administered doses of remifentanil during induction and maintenance of anesthesia

    Time frame: day 1

  3. delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia

    Time frame: day 1

  4. hemodynamic abnormalities requiring treatment

    Time frame: day 1

  5. % of time with a BIS index between 40 and 60

    Time frame: day 1

  6. postoperative morphine requirement

    Time frame: day 1

  7. incidence of postoperative nausea and vomiting

    Time frame: day 1

  8. % of patients with an explicit memorisation of the intraoperative period

    Time frame: second postoperative day

07

Study locations

1 site
  • Hopital Tenon
    Paris, 75020, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01154738
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
Jul 1, 2010
Start date
Jan 2011
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Nov 3, 2016

Study contacts

Marc Fischler, MD
study chair · Hôpital Foch

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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