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Completed

NCT Number: NCT02597140

Pilot Study of Effect of Intravenous Lidocaine on Propofol Requirement 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.

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Key information

Conditions

Anesthesia, Intravenous; Surgery, Plastic

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chung-Ang University Hospital

Seoul, 156-755, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

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.

normal saline

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.

Other names: 0.9% saline

Propofol

Drug

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

Other names: Presofol MCT

Primary outcomes

  1. 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

  1. postoperative pain

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Chung-Ang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2015
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.