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Clinical Trials/NCT02597140
NCT02597140
Completed
Phase 4

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

Chung-Ang University Hosptial, Chung-Ang University College of Medicine1 site in 1 country40 target enrollmentAugust 2015

Overview

Phase
Phase 4
Intervention
lidocaine
Conditions
Anesthesia, Intravenous; Surgery, Plastic
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Enrollment
40
Locations
1
Primary Endpoint
total propofol requirements
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
May 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Chongwha Baek

Professor

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

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: lidocaine

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.

Intervention: propofol

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.

Intervention: normal saline

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.

Intervention: propofol

Outcomes

Primary Outcomes

total propofol requirements

Time Frame: 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 Outcomes

  • postoperative pain(30 minutes, 2 hours, and 4 hours after surgery)

Study Sites (1)

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