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

Sponsor

Pontificia Universidad Catolica de Chile (Other)

Overall Status

Completed

CT.gov ID

NCT01366300

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

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	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.

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

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)

Procedure: Placement of arterial line

Outcome Measures

Primary Outcome Measures

Total propofol requirements during bispectral index guided general anesthesia [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01366300

Other Study ID Numbers:

LPBIS-UC-2010

First Posted:

Jun 6, 2011

Last Update Posted:

Jun 6, 2011

Last Verified:

Mar 1, 2011

Additional relevant MeSH terms:

Lidocaine

Propofol

Study Results

No Results Posted as of Jun 6, 2011