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

NCT02597140 | Completed Phase 4 DMC

• 1 other identifier: ChungAng
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Intravenous; Surgery, Plastic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• postoperative pain

  30 minutes, 2 hours, and 4 hours after surgery

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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; Drug: propofol

Control group

PLACEBO COMPARATOR

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: normal saline; Drug: propofol

Interventions

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.

Lidocaine group

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.

Also known as: 0.9% saline

Control group

propofol DRUG

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

Also known as: Presofol MCT

Control group; Lidocaine group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

MeSH Terms

Interventions

Lidocaine; Saline Solution; Propofol

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 5, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

KR (1)