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

Phase 4

Completed

• Conditions: Intravenous Anesthetic Interaction "Unrecognized Condition"
• Interventions: Drug: Intravenous lidocaine infusion; Other: Placebo (0.9% saline infusion); Drug: Propofol 1% (intravenous infusion); Procedure: Placement of arterial line

• Registration Number: NCT01366300
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Study Start: 2010-06
• Status Verified: 2011-03
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-03
• Last Update Submitted: 2011-06-03
• Study First Posted: 2011-06-06
• Last Update Posted: 2011-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous lidocaine infusion	Intravenous lidocaine infusion	Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intravenous lidocaine infusion	Propofol 1% (intravenous infusion)	Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intravenous 0.9% saline infusion	Placebo (0.9% saline infusion)	Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intravenous 0.9% saline infusion	Propofol 1% (intravenous infusion)	Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intravenous lidocaine infusion	Placement of arterial line	Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion
Intravenous 0.9% saline infusion	Placement of arterial line	Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Hospital Clínico Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, RM, Chile