CompletedNot Applicable

Efficacy of Propofol-Ketamine and Sevoflurane in Children Undergoing Magnetic Resonance Imaging

Turkey (Türkiye)230 participantsStarted 2025-06-19

Plain-language summary

Magnetic resonance imaging (MRI) is becoming increasingly important in the diagnosis and follow-up of pediatric diseases. However, successful MRI requires complete and prolonged immobility, which can be challenging for young children and infants. To overcome this challenge, various anesthesia techniques are employed by anesthesiologists. The ideal anesthesia method for children during MRI should be both safe and enable rapid recovery, allowing the child to remain still during the procedure while minimizing risks during the recovery period. \*\*Sevoflurane has become a popular choice for this purpose due to its rapid onset, limited respiratory side effects at low concentrations, reduced airway irritation, and hemodynamic stability. However, propofol and ketamine, used as an alternative sedation method, are also being increasingly utilized during these procedures. The major side effects of propofol include respiratory depression, apnea, loss of protective reflexes, and hemodynamic instability. To minimize these side effects, some experts recommend the combined use of propofol and ketamine. This combination provides effective sedation while also contributing to a reduction in side effects. In this context, the aim of our study is to compare the efficacy of intravenous propofol and ketamine with sevoflurane administered via a face mask during pediatric MRI.

Who can participate

Age range

3 Months – 10 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: * Ages 3 months to 10 years. * Classified as ASA I-II according to the American Society of Anesthesiologists (ASA) classification. * Patients scheduled for MRI at Kocaeli City Hospital MRI unit. Exclusion Criteria: * Families or children who do not consent to participate in the study. * Patients with allergies to ketamine, propofol, midazolam, or sevoflurane. * Patients with known pulmonary or cardiac diseases. * Patients with known congenital craniofacial or neck anomalies. * Patients dependent on oxygen therapy. * Patients with a recent respiratory tract infection within the past 2 weeks. * Patients requiring tracheal intubation, laryngeal mask, or ventilator support. * Patients at risk of upper airway obstruction. * Patients with behavioral problems. * Patients with gastroesophageal reflux disease. * Patients with lethargy, stupor, or unresponsiveness to stimuli due to any cause * Patients with active use of antiepileptic or antipsychotic medications

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

Recovery time

Timeframe: From the end of the MRI scan until the patient reaches a Ramsay Sedation Scale (RSS) score of 2, assessed for a maximum of 60 minutes.

Trial details

NCT IDNCT06832683

SponsorKocaeli City Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-09-08

View on ClinicalTrials.gov More Recovery Period trials