Lidocaine VS Hemodynamic, Metabolic and Hormonal Response

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hemodynamic Response, Acute Appendicitis, Complication of Treatment, Opioid Consumption, Pneumoperitoneum

Intervention / Treatment
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* Drug: Intravenous lidocaine
* Drug: Normal saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status class 1E, 2E, 3E; Patients undergoing laparoscopic appendectomy. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>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. | Drug: Intravenous lidocaine<br>* Intraoperative intravenous lidocaine infusion.<br>* Other names: IVL;|
| Placebo Comparator: Control<br>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. | Drug: Normal saline infusion<br>* Intraoperative intravenous normal saline infusion.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic reaction to tracheal intubation | A change in arterial blood pressure more than 20% from baseline. The fractions of patients in each group will be compared. | Before intubation - immediately after intubation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic response to laparoscopic procedure | Glucose [mg/dl] levels will be measured and compared before and after 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 | Lidocaine level [mcg/ml] will be measured after initial bolus and just before the end of its infusion. | First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation. | 
| Side effects of lidocaine | Side effects of lidocaine will be assessed by recording the rates of the following complications: arrythmia, hypotension (defined as <70th percentile for age), allergic reaction. | From the beginning of drug infusion until transfer to the postanesthesia care unit (10 minutes after extubation). | 
| Hormonal response to laparoscopic procedure | Cortisol levels [mcg/dl] will be measured and compared before and after laparoscopic procedure. | First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multimodal analgesia, lidocaine, intravenous lidocaine, laparoscopic appendectomy, children, pediatric population, adjuvant, metabolic stress response, hormonal response