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Hemodynamic ResponsePhase 4NCT05238506

Lidocaine VS Hemodynamic, Metabolic and Hormonal Response

A Phase 4 study testing Intravenous lidocaine and Normal saline infusion in people with Hemodynamic Response and Acute Appendicitis, run by Medical University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 months to 18 years
What is being tested?
Intravenous lidocaine and Normal saline infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
132 participants
Where
1 sitePoland
Study dates
12 Mar 2022to 8 Aug 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • University Clinic Centre of Medical University of Warsaw

    Warsaw, 02-091

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
Intravenous lidocaine, Normal saline infusion
Keywords
multimodal analgesia, lidocaine, intravenous lidocaine, laparoscopic appendectomy, children, pediatric population, adjuvant, metabolic stress response, hormonal response
Medical subject headings
Appendicitis, Pneumoperitoneum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous lidocaineDrug

    Also called IVL

    Intraoperative intravenous lidocaine infusion.

  • Normal saline infusionDrug

    Also called Placebo

    Intraoperative intravenous normal saline infusion.

Study groups in NCT05238506
Study groupRoleWhat they receive
LidocaineExperimental1% 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.
Receives: Drug: Intravenous lidocaine
ControlPlacebo comparator0.9% 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.
Receives: Drug: Normal saline infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Before intubation - immediately after intubation.

Secondary outcomes (4)

  1. Metabolic response to laparoscopic procedure

    Glucose [mg/dl] levels will be measured and compared before and after laparoscopic procedure.

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

  2. Lidocaine blood level

    Lidocaine level [mcg/ml] will be measured after initial bolus and just before the end of its infusion.

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

  3. 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.

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

  4. Hormonal response to laparoscopic procedure

    Cortisol levels [mcg/dl] will be measured and compared before and after laparoscopic procedure.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start12 Mar 2022
  3. Primary completion8 Aug 2023
  4. Study completion8 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05238506
Sponsor's protocol ID
Lido02
Status last verified
Oct 2023
First submitted
21 Jan 2022
Last updated
31 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.

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.

    PubMed 23839320

  • 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.

    PubMed 33397287

  • 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.

    PubMed 41226876

  • 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.

    PubMed 39794723

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravenous lidocaine and Normal saline infusion in people with Hemodynamic Response and Acute Appendicitis, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemodynamic reaction to tracheal intubation (time frame: Before intubation - immediately after intubation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05238506, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.

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