Lidocaine VS Hemodynamic, Metabolic and Hormonal Response

NCT05238506 | Completed Phase 4

• 1 other identifier: Lido02
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Metabolic response to 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

  First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.

• Side effects of lidocaine

  From the beginning of drug infusion until transfer to the postanesthesia care unit (10 minutes after extubation).

• Hormonal response to laparoscopic procedure

  First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.

Other Outcomes (1)

• The requirement for opioids during anesthesia

  From the induction of anesthesia through to postanesthesia care unit admission (10 minutes after extubation).

Study Arms (2)

Lidocaine

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Intravenous lidocaine DRUG

Intraoperative intravenous lidocaine infusion.

Also known as: IVL

Lidocaine

Normal saline infusion DRUG

Intraoperative intravenous normal saline infusion.

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ASA physical status class 1E, 2E, 3E;
• Patients undergoing laparoscopic appendectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

University Clinic Centre of Medical University of Warsaw

Warsaw, 02-091, Poland

Location

Related Publications (5)

• 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.

  PMID: 23839320 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33397287 BACKGROUND

• Kaszynski M, Stankiewicz B, Kalicka A, Mikolap K, Olszanecka M, Rybka Z, Witt P, Darowski M, Pagowska-Klimek I. Comparison of Opioid Consumption During Paediatric Anaesthesia with and Without a Mandatory Protocol: A Retrospective Cohort Study. J Clin Med. 2025 Oct 22;14(21):7481. doi: 10.3390/jcm14217481.

  PMID: 41226876 DERIVED

• Kaszynski M, Kuczerowska A, Pietrzyk J, Sawicki P, Witt P, Stankiewicz B, Darowski M, Pagowska-Klimek I. Influence of intravenous lidocaine infusion on haemodynamic response to tracheal intubation and metabolic-hormonal responses during laparoscopic procedures in children: a randomised controlled trial. BMC Anesthesiol. 2025 Jan 10;25(1):23. doi: 10.1186/s12871-024-02885-z.

  PMID: 39794723 DERIVED

MeSH Terms

Conditions

Appendicitis; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Peritoneal Diseases

Study Officials

• Maciej Kaszyński

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The drug or placebo(normal saline) will be placed in a syringe by the principal investigator. Only principal investigator will be aware of the participants allocation. The principal investigator will not be involved in the process of: recruitment, providing an intervention, or outcomes assessment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 14, 2022
• Study Start: March 12, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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.
• Access Criteria: The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.

Locations

PL (1)