CompletedNot Applicable

The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children

102 participantsStarted 2012-11

Plain-language summary

Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating airway properties, rapid induction and emergence. However, it is associated with emergence agitation (EA) in children. EA may cause injury to the child or to the surgical site and is a cause of stress to both caregivers and families. Various pharmacologic agents have been suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This study was designed to compare the effects of remifentanil and remifentanil combining alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.

Who can participate

Age range

3 Years – 9 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 who were scheduled to undergo ophthalmic surgery under general anesthesia Exclusion Criteria: * developmental delay, neurologic or psychologic disease, * history of sleep apnea, * or history of general anesthesia

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

the incidence of emergence agitation

Timeframe: during recovery time in PACU (within 1 hour)

Trial details

NCT IDNCT02486926

SponsorHallym University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-07

View on ClinicalTrials.gov More Adverse Effect of Other General Anesthetics trials