Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation (NCT06312618) | Clinical Trial Compass
CompletedPhase 4
Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation
Egypt80 participantsStarted 2024-03-15
Plain-language summary
The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:
• Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?
Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane.
Who can participate
Age range
3 Years – 7 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:
* Pediatric patients from 3 to 7 years.
* American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
* Patients undergo squint surgery.
Exclusion Criteria:
* Declining to give written informed consent by patient legal guardian.
* Age younger than 3 years or older than 7 years.
* ASA classification ≥ III.
* History of allergy to the medications used in the study or egg products.
* Psychiatric disorder
* Other co-morbidities or congenital anomalies or neurological.
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 overall incidence of postoperative Emergence Agitation
Timeframe: EA incidence and severity will be determined using (PAED) scale at extubation (E0), upon arrival to the Post Anesthesia Care Unit (PACU) E1 and after 15 minute (E2), then after 30 minute in the PACU (E3).