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

September 8, 2025 updated by: Bedirhan Günel, Kocaeli City Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İ̇zmi̇t
      • Kocaeli, İ̇zmi̇t, Turkey (Türkiye), 41100
        • Bedirhan Günel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group P
Intravenous propofol and ketamine will be administered to the patients in this group.
Drug: Propofol
In Group P, 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.
Other Names:
  • Group P
Drug: Ketamine
In Group P, 1 mg/kg, single dose ketamine was administered intravenously and all additional doses were recorded.
Other Names:
  • Group P
Active Comparator: Group S
Sevoflurane will be administered via a procedural oxygen mask to the patients in this group.
Drug: Sevoflurane
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%.
Other Names:
  • Group S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery time
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge time
Time Frame: 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.
From the completion of the procedure until the child's Modified Aldrete Score reaches 10, assessed for a maximum of 60 minutes.
Anesthesia duration
Time Frame: 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.
From the start of anesthesia induction to the completion of the MRI procedure, assessed for a maximum of 60 minutes.
Incidence of hypoxemia
Time Frame: Continuous SpO2 monitoring will be performed throughout the procedure]
Incidence of hypoxemia during sedation (defined as SpO2 < 93%).
Continuous SpO2 monitoring will be performed throughout the procedure]
Number of hypoxemia episodes
Time Frame: 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
Continuous SpO2 monitoring will be performed throughout the procedure
Duration of hypoxemia
Time Frame: Continuous SpO2 monitoring will be performed throughout the procedure
defined as the time to reach SpO2 ≥ 93%
Continuous SpO2 monitoring will be performed throughout the procedure
Minimum SpO2
Time Frame: Continuous SpO2 monitoring will be performed throughout the procedure]
observed during the procedure
Continuous SpO2 monitoring will be performed throughout the procedure]
airway management
Time Frame: 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).
Interventions related to airway management causing interruptions during the procedure
Additional anesthetic intervention
Time Frame: during procedure
Additional anesthetic intervention due to undesired movements disrupting image quality and causing interruptions in the procedure.
during procedure
Image quality
Time Frame: 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).
immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli City Hospital

Investigators

  • Principal Investigator: Bedirhan Günel, MD, Kocaeli City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2025

Primary Completion (Actual)

September 8, 2025

Study Completion (Actual)

September 8, 2025

Study Registration Dates

First Submitted

February 1, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSH-ANREA-BG-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Personal data and study data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoxemia

Clinical Trials on Propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe