CompletedNot Applicable

Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask for EUA in Children

Lebanon60 participantsStarted 2017-05-23

Plain-language summary

The goal of this clinical trial is to find out the optimal technique of anesthesia for eye examination in children. The main question it aims to answer is: Is propofol infusion and simple oxygen facemask associated with earlier discharge from the operating room, and hence rapid turnover and greater efficiency compared to sevoflurane via LMA? Researchers will compare time to discharge from the operating room to see if eye examination for children less than 7 years using a propofol infusion pump based anesthesia and simple oxygen facemask results in a shorter discharge time from the operating room in comparison with sevoflurane via LMA. Participants will will be assigned to receive general anesthesia by one of two treatment groups.

Who can participate

Age range

1 Year – 6 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: * Children presented to the Operating Room of the American University of Beirut Medical Center * 1 to 6 years old * With American Society of Anesthesiologists physical status 1-3 * Scheduled for ophthalmic EUA with or without laser/cryotherapy procedure Exclusion Criteria: * Children with full stomach or significant aspiration risk (including hiatal hernia) * Children who are morbidly obese or have a current upper respiratory tract infection * Children who have oropharyngeal pathology (e.g., radiotherapy for hypopharynx/larynx), tracheostomies, or a family history of malignant hyperthermia * Children of parents who refuse to give consent * Children having allergy to the anesthetics used * Any surgical procedure expected to last for more than 60 minutes

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

Time to discharge from the operating room

Timeframe: Time from the end of surgery to discharge from OR, assessed up to 40 minutes

Trial details

NCT IDNCT06656455

SponsorAmerican University of Beirut Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-08

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