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

NCT ID: NCT01366300

Last Updated: 2011-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-06-30

Brief 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.

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.

Conditions

Intravenous Anesthetic Interaction "Unrecognized Condition"

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intravenous lidocaine infusion

Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion

Group Type: ACTIVE_COMPARATOR

Intravenous lidocaine infusion

Intervention Type: 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).

Propofol 1% (intravenous infusion)

Intervention Type: 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

Intervention Type: 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.

Intravenous 0.9% saline infusion

Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion

Group Type: PLACEBO_COMPARATOR

Placebo (0.9% saline infusion)

Intervention Type: 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)

Intervention Type: 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

Intervention Type: 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.

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: OTHER

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Pontificia Universidad Católica de Chile - Departamento de Anestesiología

Principal Investigators

Fernando R Altermatt, MD

Role: PRINCIPAL_INVESTIGATOR

Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

Locations

Hospital Clínico Pontificia Universidad Católica de Chile

Santiago, RM, Chile

Countries

Chile

Other Identifiers

LPBIS-UC-2010

Identifier Type: -

Identifier Source: org_study_id