Estimation of the Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia
Overview
- Phase
- Phase 4
- Intervention
- Intravenous lidocaine infusion
- Conditions
- Intravenous Anesthetic Interaction "Unrecognized Condition"
- Sponsor
- Pontificia Universidad Catolica de Chile
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Total propofol requirements during bispectral index guided general anesthesia
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
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
Arms & Interventions
Intravenous lidocaine infusion
Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intervention: Intravenous lidocaine infusion
Intravenous lidocaine infusion
Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intervention: Propofol 1% (intravenous infusion)
Intravenous lidocaine infusion
Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intervention: Placement of arterial line
Intravenous 0.9% saline infusion
Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intervention: Placebo (0.9% saline infusion)
Intravenous 0.9% saline infusion
Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intervention: Propofol 1% (intravenous infusion)
Intravenous 0.9% saline infusion
Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intervention: Placement of arterial line
Outcomes
Primary Outcomes
Total propofol requirements during bispectral index guided general anesthesia
Time Frame: 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 Outcomes
- Evaluate effect of intravenous lidocaine infusion on waking time after general anesthesia(DAY 1.)