Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complicat… (NCT05527314) | Clinical Trial Compass
CompletedNot Applicable
Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
China110 participantsStarted 2022-08-23
Plain-language summary
As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether Remimazolam reduces the incidence of emergence agitation in children after ophthalmic surgery, compared to sevoflurane (RCT).
Who can participate
Age range
3 Years – 8 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
. ASA Ⅰ-Ⅱ
. Aged 3-8 years, weight \> 10 kg, sex was not limited；
. Children were scheduled for selective ophthalmic surgery under general anesthesia,
Exclusion criteria
. Respiratory infection was present within 4 weeks before surgery.
. Potential or presence of difficult airways, airway obstruction, sleep apnea, and other contraindications to general anesthesia.
. The blood routine or blood biochemical indexes were obviously abnormal.
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
The incidence of emergence agitation
Timeframe: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
2
The incidence of emergence agitation
Timeframe: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
3
The incidence of emergence agitation
Timeframe: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
Trial details
NCT IDNCT05527314
SponsorSecond Affiliated Hospital of Nanchang University