Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia

Summary

The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine infusion initiated and maintained during surgery, on propofol requirements during general anesthesia.

Conditions

• Intravenous Anesthetic Interaction "Unrecognized Condition"

Interventions

DRUG

Intravenous lidocaine infusion

Once the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, lidocaine 1% infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made).

OTHER

Placebo (0.9% saline infusion)

Once the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, 0.9% saline infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made).

DRUG

Propofol 1% (intravenous infusion)

Propofol is administered according to a widely-accepted pharmacokinetic model, initially dosed to a target controlled infusion (TCI) of 4.5 micrograms/ml, and titrated by step increases of 0.5 every minute until loss of conscience is obtained and BIS values are less than 50. During the maintenance phase of anesthesia propofol TCI is actively titrated to maintain BIS values between 40 and 50. If BIS is out of this range for more than 10 seconds, propofol is adjusted in 0.5 ug/mc to maintain BIS values in the predetermined limits.

PROCEDURE

Placement of arterial line

An arterial line was placed in the anesthetised patient´s right arm by the investigator and arterial samples were obtained every 10 minutes since initiation of the study infusion to determine plasmatic lidocaine and propofol levels (if the infusion was saline the samples were not analyzed). The arterial line was removed before the end of surgery.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile

  lead OTHER

Principal Investigators

• Fernando R Altermatt, MD · Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2011-06-30

Completion

2011-06-30

Countries

• Chile

Study Locations