Lidocaine and Closed-Loop Anesthesia System

Phase 3CompletedNCT01154738

Hopital Foch82 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Anesthesia

Interventions

LidocaineDRUG

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

PlaceboDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Tenon

Paris, France

Outcomes

Primary Outcomes

administered dose of propofol during maintenance of anesthesia

Time frame: day 1

Secondary Outcomes

administered dose of propofol during induction of anesthesia

Time frame: day 1

administered doses of remifentanil during induction and maintenance of anesthesia

Time frame: day 1

delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia

Time frame: day 1

hemodynamic abnormalities requiring treatment

Time frame: day 1

% of time with a BIS index between 40 and 60

Time frame: day 1

postoperative morphine requirement

Time frame: day 1

incidence of postoperative nausea and vomiting

Time frame: day 1

% of patients with an explicit memorisation of the intraoperative period

Time frame: second postoperative day

Data from ClinicalTrials.gov

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