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Clinical Trials/NCT01154738
NCT01154738
Completed
Phase 3

Influence of Lidocaine on a Closed-Loop Anesthesia System

Hopital Foch1 site in 1 country82 target enrollmentJanuary 2011
ConditionsAnesthesia
InterventionsLidocainePlacebo

Overview

Phase
Phase 3
Intervention
Lidocaine
Conditions
Anesthesia
Sponsor
Hopital Foch
Enrollment
82
Locations
1
Primary Endpoint
administered dose of propofol during maintenance of anesthesia
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
January 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

Lidocaine

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

Intervention: Lidocaine

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

administered dose of propofol during maintenance of anesthesia

Time Frame: day 1

Secondary Outcomes

  • delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia(day 1)
  • postoperative morphine requirement(day 1)
  • incidence of postoperative nausea and vomiting(day 1)
  • % of patients with an explicit memorisation of the intraoperative period(second postoperative day)
  • administered dose of propofol during induction of anesthesia(day 1)
  • administered doses of remifentanil during induction and maintenance of anesthesia(day 1)
  • hemodynamic abnormalities requiring treatment(day 1)
  • % of time with a BIS index between 40 and 60(day 1)

Study Sites (1)

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