Lidocaine and Closed-Loop Anesthesia System (LoopLido)

Influence of Lidocaine on a Closed-Loop Anesthesia System

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Lidocaine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Hopital Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
administered dose of propofol during maintenance of anesthesia	day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
administered dose of propofol during induction of anesthesia	day 1
administered doses of remifentanil during induction and maintenance of anesthesia	day 1
delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia	day 1
hemodynamic abnormalities requiring treatment	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
% of time with a BIS index between 40 and 60	day 1

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 25, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: November 2, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2010/18; 2010-019979-29 (EudraCT Number)