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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Intravenous; Surgery, Plastic
• Intervention / Treatment: Drug: lidocaine; Drug: propofol; Drug: normal saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-755
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Drug: propofol; Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.; Other Names: Presofol MCT
Placebo Comparator: 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.	Drug: propofol; Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.; Other Names: Presofol MCT; 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.; Other Names: 0.9% saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Lidocaine
• Other Study ID Numbers: ChungAng