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Completed

NCT Number: NCT01154738

Lidocaine and Closed-Loop Anesthesia System

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

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital Tenon

Paris, 75020, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Drug

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

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

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Influence of Lidocaine on a Closed-Loop Anesthesia System

Acronym: LoopLido

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2010
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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