Effect of Different Concentrations of Sevoflurane for Anesthesia Induction in Pediatric Ophthalmi… (NCT07450495) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Different Concentrations of Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Surgery
China80 participantsStarted 2025-02-25
Plain-language summary
This randomized controlled trial aims to compare the effectiveness and safety of 6% versus 8% sevoflurane inhalation induction in pediatric patients undergoing minor ophthalmic surgery. The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes include hemodynamic parameters, induction time, recovery time, and adverse events.
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 aged 1 to 6 years (12-72 months)
* Scheduled to undergo minor ophthalmic surgery (e.g., chalazion excision) under general anesthesia
* American Society of Anesthesiologists (ASA) physical status I
* Assessed as suitable for inhalation anesthesia by anesthesiologists
* Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
* ASA physical status II or higher
* Known hepatic or renal dysfunction
* Congenital heart disease
* History of malignant hyperthermia
* Known allergy to sevoflurane
* History of asthma or severe respiratory disease
* Upper respiratory tract infection within the past 4 weeks
* Anticipated difficult airway
* Refusal of participation by parents or legal guardians
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
1
PAED score
Timeframe: Within 30 minutes after recovery
Trial details
NCT IDNCT07450495
SponsorJoint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong