Clinical trial NCT05238506: Lidocaine VS Hemodynamic, Metabolic and Hormonal Response
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamic Response
Acute Appendicitis
Complication of Treatment
Opioid Consumption
Pneumoperitoneum
Keywords: multimodal analgesia
lidocaine
intravenous lidocaine
laparoscopic appendectomy
children
pediatric population
adjuvant
metabolic stress response
hormonal response
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemodynamic reaction to tracheal intubation
timeFrame: Before intubation - immediately after intubation.
Secondary outcomes:
measure: Metabolic response to laparoscopic procedure
timeFrame: First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.
measure: Lidocaine blood level
timeFrame: First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.
measure: Side effects of lidocaine
timeFrame: From the beginning of drug infusion until transfer to the postanesthesia care unit (10 minutes after extubation).
measure: Hormonal response to laparoscopic procedure
timeFrame: First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.
Other outcomes:
measure: The requirement for opioids during anesthesia
timeFrame: From the induction of anesthesia through to postanesthesia care unit admission (10 minutes after extubation).
Locations:
city: Warsaw
country: Poland
facility: University Clinic Centre of Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Maciej Kaszyński
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.