The Effect of Intravenous Lidocaine Infusion on Hemodynamic Reaction to Tracheal Intubation, as Well as Metabolic and Hormonal Response to Laparoscopic Procedure in Children: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Hemodynamic reaction to tracheal intubation
研究概览
简要总结
Intravenous lidocaine - a potent local anesthetic with analgesic and anti- inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. In children population promising but limited evidence is available. The study has been planned to evaluate the efficacy of continuous intravenous infusion of lidocaine in alleviation of hemodynamic reaction to tracheal intubation, as well as metabolic and hormonal response to laparoscopic procedure in children.
详细描述
Laryngoscopy and endotracheal intubation are associated with noxious stimulation. Exacerbated circulatory system response may present as hypertension or arrhythmias including cardiac arrest. A sudden change in hemodynamic status connected with painful stimulation may precipitate deterioration in cerebral blood flow, especially in patients with intracranial hypertension (traumatic brain injury, intracranial hemorrhage, active hydrocephalus, etc). Many interventions have been applied to attenuate harmful hemodynamic reaction. One of them is intravenous lidocaine infusion. According to available data lidocaine is superior to placebo in attenuating systolic, diastolic and mean arterial pressure changes in children. Our study will focus on assessing hemodynamic stability preserving properties during induction of anesthesia and tracheal intubation. Blood pressure will be recorded and analyzed. The secondary aim is to examine intravenous lidocaine infusion in terms of reducing systemic response to surgical stress. Cortisol and glucose levels will be measured before skin incision, and immediately after the end of surgery. Side effects and serum lidocaine levels will be recorded to determine safety of the examined intervention. Similar pattern of infusion was investigated in RCT concerning children population - the toxic plasma level of 5 mcg/ml was not reached. Studies on children population have promising results but high quality randomized controlled trials are still missing. The proposed study has been planned to evaluate the efficacy of continuous infusion of lidocaine as an adjunct to standard general anesthesia (involving intravenous induction and opioid with sevoflurane maintenance) in attenuating hemodynamic reaction to tracheal intubation, as well as metabolic and hormonal response to surgical procedure in children undergoing laparoscopic appendectomy.
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)
盲法说明
The drug or placebo(normal saline) will be placed in a syringe by the principal investigator. Only principal investigator will be aware of the participants allocation. The principal investigator will not be involved in the process of: recruitment, providing an intervention, or outcomes assessment.
入排标准
- 年龄范围
- 18 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status class 1E, 2E, 3E;
- •Patients undergoing laparoscopic appendectomy.
排除标准
- •Allergy to local anesthetics or contraindications for the use of lidocaine;
- •ASA physical status class 4E or higher;
- •Severe cardiovascular disease;
- •Preoperative bradycardia;
- •Preoperative atrioventricular block;
- •Renal failure;
- •Chronic treatment with analgesics;
- •Legal guardians' refusal.
研究组 & 干预措施
Lidocaine
1% lidocaine intravenous bolus of 0.15 ml/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 0.15 ml/kg/h intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.
干预措施: Intravenous lidocaine (Drug)
Control
0.9% NaCl intravenous bolus of 0.15 ml/kg over 5 min before induction of anesthesia followed by 0.9% NaCl infusion at 0.15 ml/kg/h intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.
干预措施: Normal saline infusion (Drug)
结局指标
主要结局
Hemodynamic reaction to tracheal intubation
时间窗: Before intubation - immediately after intubation.
A change in arterial blood pressure more than 20% from baseline. The fractions of patients in each group will be compared.
次要结局
- Metabolic response to laparoscopic procedure(First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.)
- Lidocaine blood level(First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.)
- Hormonal response to laparoscopic procedure(First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.)
- Side effects of lidocaine(From the beginning of drug infusion until transfer to the postanesthesia care unit (10 minutes after extubation).)
研究者
Maciej Kaszyński
physician
Medical University of Warsaw