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

Not Applicable

Recruiting

• Conditions: Recovery Period; Hypoxemia; Patient Safety
• Interventions: Drug: Propofol; Drug: Sevoflurane; Drug: Ketamine

• Registration Number: NCT06832683
• Lead Sponsor: Kocaeli City Hospital

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.

Study Timeline

• Study First Submitted: 2025-02-01
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Status Verified: 2025-06
• Study Start: 2025-06-19
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Propofol	Intravenous propofol and ketamine will be administered to the patients in this group.
Group P	Ketamine	Intravenous propofol and ketamine will be administered to the patients in this group.
Group S	Sevoflurane	Sevoflurane will be administered via a procedural oxygen mask to the patients in this group.

Primary Outcome Measures

Name	Time	Method
Recovery time	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.	Recovery time was defined as the duration (measured in minutes) from the end of the MRI scan until the patient reached a Ramsay Sedation Scale (RSS) score of 2. The Ramsay Sedation Scale ranges from 1 (awake) to 6 (deep sedation), with higher scores indicating deeper sedation. In this study, an RSS score of 2 was considered the criterion for sufficient recovery.

Secondary Outcome Measures

Name	Time	Method
Discharge time	From the completion of the procedure until the child's Modified Aldrete Score reaches 10, assessed for a maximum of 60 minutes.	Discharge time was defined as the duration (measured in minutes) from the completion of the procedure until the child's Modified Aldrete Score reached 10, indicating readiness for discharge. The Modified Aldrete Score ranges from 0 to 10, with higher scores representing better recovery status. A score of 10 was considered the criterion for discharge readiness in this study.
Anesthesia duration	From the start of anesthesia induction to the completion of the MRI procedure, assessed for a maximum of 60 minutes.	Anesthesia duration was defined as the time (measured in minutes) from the start of anesthesia induction until the completion of the MRI procedure.
Incidence of hypoxemia	Continuous SpO2 monitoring will be performed throughout the procedure]	Incidence of hypoxemia during sedation (defined as SpO2 \< 93%).
Duration of hypoxemia	Continuous SpO2 monitoring will be performed throughout the procedure	defined as the time to reach SpO2 ≥ 93%
Number of hypoxemia episodes	Continuous SpO2 monitoring will be performed throughout the procedure	a new episode was recorded if SpO2 fell below 93% again after reaching SpO2 ≥ 93% for at least 30 seconds
Minimum SpO2	Continuous SpO2 monitoring will be performed throughout the procedure]	observed during the procedure
airway management	Interventions related to airway management causing interruptions during the procedure	Procedure interruptions due to airway interventions during the procedure (chin lift, jaw thrust, mask ventilation, need for suctioning).
Image quality	immediately after the procedure	Image quality was evaluated by a radiologist who was not involved in the imaging process, using a 10-point analog scale (0: unacceptable, 5: diagnosis not possible, 8: acceptable, 10: excellent).
Additional anesthetic intervention	during procedure	Additional anesthetic intervention due to undesired movements disrupting image quality and causing interruptions in the procedure.

Trial Locations

Locations (1)

Bedirhan Günel; 🇹🇷 Kocaeli, İ̇zmi̇t, Turkey