Anesthesia, Intravenous; Surgery, Plastic
Conditions
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.
Interventions
DRUGlidocaine
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.
DRUGnormal 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.
DRUGpropofol
Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.
Sponsors
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
South Korea
Outcome results
None listed