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Lidocaine and Closed-Loop Anesthesia System (LoopLido)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01154738
First received: June 25, 2010
Last updated: September 22, 2016
Last verified: September 2016
  Purpose
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.

Condition Intervention Phase
Anesthesia
Drug: Lidocaine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Lidocaine on a Closed-Loop Anesthesia System

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • administered dose of propofol during maintenance of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • administered dose of propofol during induction of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • administered doses of remifentanil during induction and maintenance of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • hemodynamic abnormalities requiring treatment [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • % of time with a BIS index between 40 and 60 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • postoperative morphine requirement [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • incidence of postoperative nausea and vomiting [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • % of patients with an explicit memorisation of the intraoperative period [ Time Frame: second postoperative day ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: January 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154738

Locations
France
Hopital Tenon
Paris, France, 75020
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01154738     History of Changes
Other Study ID Numbers: 2010/18 
Study First Received: June 25, 2010
Last Updated: September 22, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
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

ClinicalTrials.gov processed this record on September 23, 2016