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Completed

NCT Number: NCT01366300

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

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.

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Key information

Conditions

Intravenous Anesthetic Interaction "Unrecognized Condition"

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínico Pontificia Universidad Católica de Chile

Santiago, RM, 8330024, Chile

About this study

Use of intravenous lidocaine as a coadjuvant agent during general anesthesia has increased. Lidocaine infusion during and after abdominal surgery decreases postoperative pain and reduces ileus duration, reducing patient´s hospital stay and opioid consumption. Intravenous lidocaine´s effect on other intravenous anesthetics is unclear, and there are no present studies evaluating its interaction on hypnotic anesthetic requirements when using a BIS (Bispectral Index) monitor to maintain an adequate depth of anesthesia. We therefore decided to conduct a randomized controlled trial to evaluate the interaction of systemic lidocaine infusion, initiated and maintained during surgery, on propofol requirements and anesthetic depth as measured by BIS.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-II patients,
  • Between 20 and 65 years of age
  • Programed for elective laparoscopic cholecystectomy
  • Eligible for total intravenous anesthesia with propofol

Exclusion criteria

  • Unwillingness to participate in the study
  • Adverse reactions to the drugs used in the study
  • Use of medications that interfere in local anesthetic metabolism
  • History of liver disease, kidney failure, hypoalbuminemia, hypocalcemia or hypophosphatemia
  • History of drug or alcohol abuse
  • Chronic use of benzodiazepines

Treatment and study plan

intravenous lidocaine infusion

Drug

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).

Placebo (0.9% saline infusion)

Other

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).

Propofol 1% (intravenous infusion)

Drug

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.

Placement of arterial line

Procedure

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.

Primary outcomes

  1. Total propofol requirements during bispectral index guided general anesthesia

    Time frame: DAY 1.

    During and after elective laparoscopic cholecystectomy. Patients' anesthetic depth will be monitored during the intra-operative period using a BIS monitor. Patients' follow up considers the immediate post-operative period at the recovery room (PACU), and it will continue until patients' discharge from the hospital (average 3 days postoperatively).

Secondary outcomes

  1. Evaluate effect of intravenous lidocaine infusion on waking time after general anesthesia

    Time frame: DAY 1.

    Immediately after elective laparoscopic cholecystectomy, during PACU stay. Patients' follow up considers the immediate post-operative period at the recovery room (PACU), and it will continue until patients' discharge from the hospital (average 3 days postoperatively).

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 6, 2011
Registry last updated
Jun 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.