TerminatedPhase 4

Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients

Stopped: Recruitment finished earlier, because all 40 patients enrolled

40 participantsStarted 2008-02

Plain-language summary

To describe laryngeal and respiratory reflex responses after controlled laryngeal stimulation in pediatric patients anesthetized with sevoflurane and to compare the evoked responses at two levels of anesthesia. To determine whether laryngeal and respiratory reflex responses after controlled laryngeal stimulation are completely suppressed in subjects when anesthetized with a MACEI95 (EI = endotracheal intubation) sevoflurane Hypothesis: The incidence of apnea with laryngospasm evoked by laryngeal stimulation will be reduced by 20% (from 25% to 5%) when the end-tidal concentration of sevoflurane is increased from 2.5% (MAC50) to 4.7% (MACEI95)

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: * ASA I + II * Elective intervention under general anesthesia Exclusion Criteria: * Reactive airway disease * Respiratory tract infection (previous 2 weeks) * Malignant hyperthermia * Neuromuscular disease * Cardiac disease

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 closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation

Timeframe: 5min

Trial details

NCT IDNCT00665418

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-08

View on ClinicalTrials.gov More Laryngospasm trials