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Lidocaine and Closed-Loop Anesthesia System (LoopLido)

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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

Study Description
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Brief Summary:
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Lidocaine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Lidocaine on a Closed-Loop Anesthesia System
Study Start Date : January 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Lidocaine
Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine
 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
Placebo Comparator: Placebo
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
 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


Outcome Measures
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Primary Outcome Measures :
  1. administered dose of propofol during maintenance of anesthesia [ Time Frame: day 1 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • patients with a pace-maker
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154738


Locations
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France
Hopital Tenon
Paris, France, 75020
Sponsors and Collaborators
Hopital Foch
Investigators
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Study Chair: Marc Fischler, MD Hôpital Foch
More Information
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01154738    
Other Study ID Numbers: 2010/18
2010-019979-29 ( EudraCT Number )
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action