Pilot Study of Effect of Intravenous Lidocaine on Propofol Requirement During Monitored Anesthesia Care in Facial Plastic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- total propofol requirements
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: lidocaine (Drug)
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.
干预措施: propofol (Drug)
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.
干预措施: normal saline (Drug)
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.
干预措施: propofol (Drug)
结局指标
主要结局
total propofol requirements
时间窗: 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.
次要结局
- postoperative pain(30 minutes, 2 hours, and 4 hours after surgery)
研究者
Chongwha Baek
Professor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine