Clinical trial NCT06832683: Efficacy of Propofol-Ketamine and Sevoflurane in Children Undergoing Magnetic Resonance Imaging
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Recovery Period
Hypoxemia
Patient Safety
Keywords: recovery period
Hypoxemia
Patient Safety
Sedation, Moderate
propofol
ketamine
sevoflurane
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-18
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective, Randomized, Parallel-Group Study
Primary purpose: OTHER

Brief 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.

Detailed description: Participants were randomized in a 1:1 ratio using a computer program, stratified based on MRI durations, and divided into two groups: Group S and Group P.

All participants received intravenous midazolam at a dose of 0.05 mg/kg (max 2 mg). During MRI, all patients were monitored with pulse oximetry and end-tidal CO2, and procedural oxygen masks (POM) were applied to deliver oxygen at a flow rate of 5 L/min. For Group S, 8% sevoflurane was administered for induction via the procedural oxygen mask for 2 minutes through the external output of the anesthesia machine. The concentration was then reduced to 2%. If any undesired movements occurred, they were recorded, and the sevoflurane concentration was increased by 0.5%.

In Group P, 1 mg/kg ketamine was administered intravenously, followed by 1.0 mg/kg propofol as a bolus. In the event of undesired movements, an additional 0.5 mg/kg of propofol was administered, and all additional doses were recorded. The target sedation level was set at a Ramsay Sedation Scale (RSS) score of 4, which was maintained throughout the procedure. At the end of the procedure, patients were awakened with verbal and tactile stimulation. Once an RSS score of 2 was achieved, they were transferred to the Post-Anesthetic Care Unit (PACU).

Vital signs, procedure durations, and drug doses were recorded for each patient during the procedure. All clinical decisions regarding the patients were made by the attending anesthesiologist. In the PACU, patients with a modified Aldrete score of 10 were deemed eligible for discharge. After discharge approval, all patients were observed in the outpatient unit for 1 hour. The study concluded at this point.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Discharge time
timeFrame: From the completion of the procedure until the child's Modified Aldrete Score reaches 10, assessed for a maximum of 60 minutes.
measure: Anesthesia duration
timeFrame: From the start of anesthesia induction to the completion of the MRI procedure, assessed for a maximum of 60 minutes.
measure: Incidence of hypoxemia
timeFrame: Continuous SpO2 monitoring will be performed throughout the procedure]
measure: Number of hypoxemia episodes
timeFrame: Continuous SpO2 monitoring will be performed throughout the procedure
measure: Duration of hypoxemia
timeFrame: Continuous SpO2 monitoring will be performed throughout the procedure
measure: Minimum SpO2
timeFrame: Continuous SpO2 monitoring will be performed throughout the procedure]
measure: airway management
timeFrame: Interventions related to airway management causing interruptions during the procedure
measure: Additional anesthetic intervention
timeFrame: during procedure
measure: Image quality
timeFrame: immediately after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Kocaeli City Hospital
name: Bedirhan Günel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmitz A, Weiss M, Kellenberger C, O'Gorman Tuura R, Klaghofer R, Scheer I, Makki M, Sabandal C, Buehler PK. Sedation for magnetic resonance imaging using propofol with or without ketamine at induction in pediatrics-A prospective randomized double-blinded study. Paediatr Anaesth. 2018 Mar;28(3):264-274. doi: 10.1111/pan.13315. Epub 2018 Jan 27.
citation: Ogurlu M, Orhan ME, Bilgin F, Sizlan A, Yanarates O, Yilmaz N. Efficacy of different concentrations of sevoflurane administered through a face mask for magnetic resonance imaging in children. Paediatr Anaesth. 2010 Dec;20(12):1098-104. doi: 10.1111/j.1460-9592.2010.03438.x.