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

NCT06832683 | Completed

• 1 other identifier: KSH-ANREA-BG-04
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Recovery Period; Hypoxemia; Patient Safety

Keywords

recovery period; Hypoxemia; Patient Safety; Sedation, Moderate; propofol; ketamine; sevoflurane

Outcome Measures

Primary Outcomes (1)

• Recovery time

  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 Outcomes (9)

• Discharge time

  From the completion of the procedure until the child's Modified Aldrete Score reaches 10, assessed for a maximum of 60 minutes.

• Anesthesia duration

  From the start of anesthesia induction to the completion of the MRI procedure, assessed for a maximum of 60 minutes.

• Incidence of hypoxemia

  Continuous SpO2 monitoring will be performed throughout the procedure]

• Number of hypoxemia episodes

  Continuous SpO2 monitoring will be performed throughout the procedure

• Duration of hypoxemia

  Continuous SpO2 monitoring will be performed throughout the procedure

Study Arms (2)

Group P

ACTIVE COMPARATOR

Intravenous propofol and ketamine will be administered to the patients in this group.

Drug: Propofol; Drug: Ketamine

Group S

ACTIVE COMPARATOR

Sevoflurane will be administered via a procedural oxygen mask to the patients in this group.

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

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%.

Also known as: Group S

Group S

Propofol DRUG

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.

Also known as: Group P

Group P

Ketamine DRUG

In Group P, 1 mg/kg, single dose ketamine was administered intravenously and all additional doses were recorded.

Also known as: Group P

Group P

Eligibility Criteria

• Age: 3 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Bedirhan Günel

Kocaeli, İ̇zmi̇t, 41100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29377404 BACKGROUND

• 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.

  PMID: 21199119 BACKGROUND

MeSH Terms

Conditions

Hypoxia; Lymphoma, Follicular

Interventions

Sevoflurane; Propofol; Ketamine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Officials

• Bedirhan Günel, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the participants will be blinded, making this a single-blind study design. The second anesthesiologist measuring the values in the PACU will also remain blinded to the group assignments.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: A Prospective, Randomized, Parallel-Group Study

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 18, 2025
• Study Start: June 19, 2025
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)