CompletedPhase 3

Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine

Switzerland80 participantsStarted 2010-09

Plain-language summary

To describe respiratory and laryngeal responses to laryngeal stimulation during propofol anesthesia in children. To determine whether the co-administration of lidocaine blunts these reflex responses. The outcome of primary interest is the reflex laryngospasm. Hypotheses: I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv. administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol (3mcg/ml). II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv. administration of lidocaine is equivalent to the response before the administration of lidocaine.

Who can participate

Age range

25 Months – 84 Months

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: * 25 - 84 months * gender: female / male * elective surgery or diagnostic procedure requiring general anesthesia Exclusion Criteria: * respiratory infection within the last 2 weeks * reactive airway disease under therapy * cardiovascular disease * neuromuscular disease * positive family history of malignant hyperthermia * known hypersensitivity to the investigational medical product * Participation in another study * Inability of the parents to read and understand the participant's information

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

Occurence of laryngospasm (defined as complete adduction of vocal cords and/or fals cords) with apnea lasting >10sec after laryngeal stimulation

Timeframe: 10 min.

Trial details

NCT IDNCT01222169

SponsorThomas Erb

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Laryngospasm trials