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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-05-31

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.

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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.

Conditions

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Anesthesia, Intravenous; Surgery, Plastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine group

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.

Group Type EXPERIMENTAL

lidocaine

Intervention Type DRUG

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.

propofol

Intervention Type DRUG

Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.

Control group

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.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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.

propofol

Intervention Type DRUG

Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.

Interventions

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lidocaine

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.

Intervention Type DRUG

normal saline

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.

Intervention Type DRUG

propofol

Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.

Intervention Type DRUG

Other Intervention Names

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0.9% saline Presofol MCT

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No