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

NCT01366300 | Completed Phase 4

• 1 other identifier: LPBIS-UC-2010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Anesthetic Interaction "Unrecognized Condition"

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  DAY 1.

Study Arms (2)

Intravenous lidocaine infusion

ACTIVE COMPARATOR

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

Drug: Intravenous lidocaine infusion; Drug: Propofol 1% (intravenous infusion); Procedure: Placement of arterial line

Intravenous 0.9% saline infusion

PLACEBO COMPARATOR

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

Other: Placebo (0.9% saline infusion); Drug: Propofol 1% (intravenous infusion); Procedure: Placement of arterial line

Interventions

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).

Intravenous lidocaine infusion

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).

Intravenous 0.9% saline infusion

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.

Intravenous 0.9% saline infusion; Intravenous lidocaine infusion

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.

Intravenous 0.9% saline infusion; Intravenous lidocaine infusion

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clínico Pontificia Universidad Católica de Chile

Santiago, RM, 8330024, Chile

Location

MeSH Terms

Interventions

Propofol; Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Fernando R Altermatt, MD

  Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 6, 2011

Record last verified: 2011-03

Locations

CL (1)