Lidocaine VS Hemodynamic, Metabolic and Hormonal Response

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum; Acute Appendicitis; Opioid Consumption; Hemodynamic Response; Complication of Treatment
• Intervention / Treatment: Drug: Intravenous lidocaine; Drug: Normal saline infusion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-091
    • University Clinic Centre of Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Intravenous lidocaine; Intraoperative intravenous lidocaine infusion.; Other Names: IVL
Placebo Comparator: 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.	Drug: Normal saline infusion; Intraoperative intravenous normal saline infusion.; Other Names: Placebo

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The requirement for opioids during anesthesia	Total amount of fentanyl in micrograms per kilogram body weight used during anesthesia.	From the induction of anesthesia through to postanesthesia care unit admission (10 minutes after extubation).

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Maciej Kaszyński, Medical University of Warsaw

Publications and helpful links

General Publications

• Qi DY, Wang K, Zhang H, Du BX, Xu FY, Wang L, Zou Z, Shi XY. Efficacy of intravenous lidocaine versus placebo on attenuating cardiovascular response to laryngoscopy and tracheal intubation: a systematic review of randomized controlled trials. Minerva Anestesiol. 2013 Dec;79(12):1423-35. Epub 2013 Jul 9.
• El-Deeb A, El-Morsy GZ, Ghanem AAA, Elsharkawy AA, Elmetwally AS. The effects of intravenous lidocaine infusion on hospital stay after major abdominal pediatric surgery. A randomized double-blinded study. Egypt J Anaesth. 2013;29(3):225-230, doi: 10.1016/j.egja.2013.02.005.
• Kaszynski M, Lewandowska D, Sawicki P, Wojcieszak P, Pagowska-Klimek I. Efficacy of intravenous lidocaine infusions for pain relief in children undergoing laparoscopic appendectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Jan 5;21(1):2. doi: 10.1186/s12871-020-01218-0.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2022
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: lidocaine; children; pediatric population; adjuvant; intravenous lidocaine; multimodal analgesia; laparoscopic appendectomy; metabolic stress response; hormonal response
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Pneumoperitoneum; Appendicitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Lido02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.

IPD Sharing Time Frame

The study protocol will be available to other researchers continuously after its publication.

The CSR will be hopefully publicated after the study completion.

• IPD Sharing Access Criteria: The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No