NCT06832683Completed
Efficacy of Propofol-Ketamine and Sevoflurane in Children Undergoing Magnetic Resonance Imaging
Comparison of the Efficacy of Intravenous Propofol-Ketamine and Sevoflurane Administered Via Face Mask in Children Undergoing Magnetic Resonance Imaging: A Prospective, Randomized, Parallel-Group Study
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 230 (actual)
- First submitted
- 1 Feb 2025
- Start date
- 19 Jun 2025
- Primary completion date
- 8 Sept 2025
- Lead sponsor
- Kocaeli City Hospital
- NCT number
- NCT06832683
What you commit to
- Study type: Interventional
- Participants enrolled: 230
- From 19 Jun 2025 to the primary completion date, 8 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients dependent on oxygen therapy.
- Patients with active use of antiepileptic or antipsychotic medications
Other illness
- Patients with allergies to ketamine, propofol, midazolam, or sevoflurane.
- Patients with known pulmonary or cardiac diseases.
- Patients with a recent respiratory tract infection within the past 2 weeks.
- Patients with gastroesophageal reflux disease.
Other
- Families or children who do not consent to participate in the study.
- Patients with known congenital craniofacial or neck anomalies.
- Patients requiring tracheal intubation, laryngeal mask, or ventilator support.
- Patients at risk of upper airway obstruction.
- Patients with behavioral problems.
- Patients with lethargy, stupor, or unresponsiveness to stimuli due to any cause
Who the study is looking for
- 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.
Age in the registry: 3 months to 10 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bedirhan Günel Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.