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

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Status and phase: Completed; Phase 4

Conditions: Anesthesia, Intravenous; Surgery, Plastic

Treatments: Drug: normal saline; Drug: propofol; Drug: lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02597140

ChungAng

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Lidocaine group

Experimental group

Description:

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.

Treatment:

Drug: lidocaine

Drug: propofol

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: propofol

Drug: normal saline