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

Purpose

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.

Condition	Intervention	Phase
Intravenous Anesthetic Interaction "Unrecognized Condition"	Drug: Intravenous lidocaine infusion Other: Placebo (0.9% saline infusion) Drug: Propofol 1% (intravenous infusion) Procedure: Placement of arterial line	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Estimation of the Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Lidocaine hydrochloride Lidocaine Propofol

U.S. FDA Resources

Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:

Total propofol requirements during bispectral index guided general anesthesia [ Time Frame: DAY 1. ] [ Designated as safety issue: No ]
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 Outcome Measures:

Evaluate effect of intravenous lidocaine infusion on waking time after general anesthesia [ Time Frame: DAY 1. ] [ Designated as safety issue: No ]
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).

Estimated Enrollment:	40
Study Start Date:	June 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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.

Arms

Assigned Interventions

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

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.

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.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366300

Locations

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

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile

Investigators

Principal Investigator:

Fernando R Altermatt, MD

Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

More Information

No publications provided

Responsible Party:	Fernando Altermatt, Pontificia Universidad Católica de Chile - Departamento de Anestesiología
ClinicalTrials.gov Identifier:	NCT01366300 History of Changes
Other Study ID Numbers:	LPBIS-UC-2010
Study First Received:	June 2, 2011
Last Updated:	June 3, 2011
Health Authority:	Chile: Institutional Review Board

Additional relevant MeSH terms:

Anesthetics
Lidocaine
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 19, 2013