Estimation of the Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total propofol requirements during bispectral index guided general anesthesia
研究概览
简要总结
The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine infusion initiated and maintained during surgery, on propofol requirements during general anesthesia.
详细描述
Use of intravenous lidocaine as a coadjuvant agent during general anesthesia has increased. Lidocaine infusion during and after abdominal surgery decreases postoperative pain and reduces ileus duration, reducing patient´s hospital stay and opioid consumption. Intravenous lidocaine´s effect on other intravenous anesthetics is unclear, and there are no present studies evaluating its interaction on hypnotic anesthetic requirements when using a BIS (Bispectral Index) monitor to maintain an adequate depth of anesthesia. We therefore decided to conduct a randomized controlled trial to evaluate the interaction of systemic lidocaine infusion, initiated and maintained during surgery, on propofol requirements and anesthetic depth as measured by BIS.
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •ASA I-II patients,
- •Between 20 and 65 years of age
- •Programed for elective laparoscopic cholecystectomy
- •Eligible for total intravenous anesthesia with propofol
排除标准
- •Unwillingness to participate in the study
- •Adverse reactions to the drugs used in the study
- •Use of medications that interfere in local anesthetic metabolism
- •History of liver disease, kidney failure, hypoalbuminemia, hypocalcemia or hypophosphatemia
- •History of drug or alcohol abuse
- •Chronic use of benzodiazepines
研究组 & 干预措施
Intravenous lidocaine infusion
Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion
干预措施: Intravenous lidocaine infusion (Drug)
Intravenous lidocaine infusion
Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion
干预措施: Propofol 1% (intravenous infusion) (Drug)
Intravenous lidocaine infusion
Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion
干预措施: Placement of arterial line (Procedure)
Intravenous 0.9% saline infusion
Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion
干预措施: Placebo (0.9% saline infusion) (Other)
Intravenous 0.9% saline infusion
Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion
干预措施: Propofol 1% (intravenous infusion) (Drug)
Intravenous 0.9% saline infusion
Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion
干预措施: Placement of arterial line (Procedure)
结局指标
主要结局
Total propofol requirements during bispectral index guided general anesthesia
时间窗: DAY 1.
During and after elective laparoscopic cholecystectomy. Patients' anesthetic depth will be monitored during the intra-operative period using a BIS monitor. Patients' follow up considers the immediate post-operative period at the recovery room (PACU), and it will continue until patients' discharge from the hospital (average 3 days postoperatively).
次要结局
- Evaluate effect of intravenous lidocaine infusion on waking time after general anesthesia(DAY 1.)