Pilot Study of Effect of Intravenous Lidocaine on Propofol Requirement in Facial Plastic Surgery

Study Overview
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Brief Summary
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The purpose of this randomized pilot study is to evaluate the effect of intravenous lidocaine on propofol requirement during BIS (Bispectral index) guided MAC (monitored anesthesia care) in facial plastic surgery.

Detailed Description
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Several studies reported the usefulness of intravenous lidocaine as a coadjuvant agent during general anesthesia. We thought that there would be an interaction between intravenous lidocaine and hypnotic agent requirement. However, there is no data regarding the effect of systemic lidocaine during MAC. We, thus, would like to perform a randomized, double-blinded pilot study to evaluate the effect of intravenous lidocaine on propofol requirement during BIS guided MAC in facial plastic surgery.

Official Title
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Pilot Study of Effect of Intravenous Lidocaine on Propofol Requirement During Monitored Anesthesia Care in Facial Plastic Surgery

Conditions
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Anesthesia, Intravenous; Surgery, Plastic

Intervention / Treatment
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* Drug: lidocaine
* Drug: normal saline
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status classification 1 or 2 patients aged 20-65 years who were undergoing elective facial plastic surgery under monitored anesthesia care Exclusion Criteria: unwillingness to participate in the study adverse reaction to the drugs used in the study use of medications that interfere in local anesthetic metabolism history of liver disease or kidney failure neurological or psychiatric disease history of drug or alcohol abuse chronic use of benzodiazepine

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>Patients will be received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. | Drug: lidocaine<br>* Patients in lidocaine group will be received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous infusion of 2 mg/kg/hr lidocaine.<br>Drug: propofol<br>* Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.<br>* Other names: Presofol MCT;|
| Placebo Comparator: Control group<br>Patients will be received an intravenous bolus injection of 1.5 mg/kg normal saline followed by a continuous normal saline infusion of 2 mg/kg/hr. | Drug: normal saline<br>* Patients in control group will be received an intravenous bolus injection of 1.5 mg/kg normal saline followed by a continuous infusion of 2 mg/kg/hr normal saline.<br>* Other names: 0.9% saline;Drug: propofol<br>* Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.<br>* Other names: Presofol MCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total propofol requirements | Patients' sedation depth will be monitored using a BIS monitor. Propofol will be administered using target controlled infusion (TCI) from targeting 60 to 80 of BIS. At the end of surgery, total propofol requirements will be examined and collected. | during monitored anesthesia care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | The outcome assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain) | 30 minutes, 2 hours, and 4 hours after surgery |