Lidocaine VS Hemodynamic, Metabolic and Hormonal Response

Acute Appendicitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05238506
• Other study ID #: Lido02
• Status: Completed
• Phase: Phase 4
• Start date: March 12, 2022
• Est. completion date: August 8, 2023

Study information

• Verified date: October 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis
• Complication of Treatment
• Hemodynamic Response
• Opioid Consumption
• Pneumoperitoneum

Intervention

Drug:
• Intravenous lidocaine
Intraoperative intravenous lidocaine infusion.
• Normal saline infusion
Intraoperative intravenous normal saline infusion.

Locations

Country	Name	City	State
Poland	University Clinic Centre of Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Primary	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	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.
Secondary	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.
Secondary	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).
Secondary	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.