Lidocaine and Closed-Loop Anesthesia System

Phase 3

Completed

• Conditions: Anesthesia
• Interventions: Drug: Placebo; Drug: Lidocaine

• Registration Number: NCT01154738
• Lead Sponsor: Hopital Foch

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-07-01
• Study Start: 2011-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
Lidocaine	Lidocaine	Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine

Primary Outcome Measures

Name	Time	Method
administered dose of propofol during maintenance of anesthesia	day 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital Tenon; 🇫🇷 Paris, France