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

Phase 4

Completed

• Conditions: Anesthesia, Intravenous; Surgery, Plastic
• Interventions: Drug: normal saline; Drug: lidocaine; Drug: propofol

• Registration Number: NCT02597140
• Lead Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Brief Summary

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

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	normal saline	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.
Lidocaine group	lidocaine	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.
Lidocaine group	propofol	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.
Control group	propofol	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.

Primary Outcome Measures

Name	Time	Method
total propofol requirements	during monitored anesthesia care	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of