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

Estimation of the 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.

Study Overview

• Status: Completed
• Conditions: Intravenous Anesthetic Interaction "Unrecognized Condition"
• Intervention / Treatment: Drug: Intravenous lidocaine infusion; Drug: Propofol 1% (intravenous infusion); Procedure: Placement of arterial line; Other: Placebo (0.9% saline infusion)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile, 8330024
      • Hospital Clínico Pontificia Universidad Católica de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous lidocaine infusion; Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion	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).; 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.
Placebo Comparator: Intravenous 0.9% saline infusion; Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion	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.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total propofol requirements during bispectral index guided general anesthesia	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).	DAY 1.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate effect of intravenous lidocaine infusion on waking time after general anesthesia	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).	DAY 1.

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Investigators: Principal Investigator: Fernando R Altermatt, MD, Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 2, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimate): June 6, 2011

Study Record Updates

• Last Update Posted (Estimate): June 6, 2011
• Last Update Submitted That Met QC Criteria: June 3, 2011
• Last Verified: March 1, 2011

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, Intravenous; Anesthetics, General; Anesthetics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Lidocaine
• Other Study ID Numbers: LPBIS-UC-2010