CompletedPhase 4

Lidocaine VS Hemodynamic, Metabolic and Hormonal Response

Poland132 participantsStarted 2022-03-12

Plain-language 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.

Who can participate

Age range

18 Months – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hemodynamic reaction to tracheal intubation

Timeframe: Before intubation - immediately after intubation.

Trial details

NCT IDNCT05238506

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-08

View on ClinicalTrials.gov More Hemodynamic Response trials