Lidocaine VS Hemodynamic, Metabolic and Hormonal Response
Condition: Hemodynamic Response; Acute Appendicitis; Complication of Treatment; Opioid Consumption; Pneumoperitoneum
MeSH terms: Appendicitis; Pneumoperitoneum
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Intravenous lidocaine; Normal saline infusion
Intervention type(s): Drug; Drug
Intervention description(s): Intraoperative intravenous lidocaine infusion.; Intraoperative intravenous normal saline infusion.
Other intervention name(s): IVL; Placebo
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: multimodal analgesia; lidocaine; intravenous lidocaine; laparoscopic appendectomy; children; pediatric population; adjuvant; metabolic stress response; hormonal response